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Trial record 1 of 1 for:    A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency | Recruiting Studies
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Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037931
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : May 11, 2021
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
American Regent, Inc.

Brief Summary:
The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

Condition or disease Intervention/treatment Phase
Heart Failure Iron-deficiency Drug: Ferric Carboxymaltose Drug: Placebo Phase 3

Detailed Description:

This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) distance for patients in heart failure with iron deficiency.

After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment.

Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3014 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Active Comparator: Ferric Carboxymaltose
Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices.
Drug: Ferric Carboxymaltose
Intravenous Iron
Other Name: Injectafer, Ferinject

Placebo Comparator: Placebo
Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.
Drug: Placebo
Normal Saline Solution
Other Name: Saline solution




Primary Outcome Measures :
  1. Incidence of death [ Time Frame: 1 year ]
  2. Incidence of hospitalization for heart failure [ Time Frame: 1 year ]
  3. Change in 6MWT distance [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (≥18 years of age) able to provide signed, written informed consent.
  2. Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization.
  3. Able and willing to perform a 6MWT at the time of randomization.
  4. Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG), valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation.

    a. Left ventricular ejection fraction ≤ 40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction ≤ 40% within 24 months of screening visit ii. Historical value of ejection fraction ≤ 30% within 36 months of screening visit

  5. Hemoglobin >9.0 g/dL and < 13.5 g/dL (females) or <15.0 g/dL (males) within 28 days of randomization.
  6. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.Patients with screening ferritin <15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization.
  7. Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) > 600 pg/mL (or BNP >200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL) .

Exclusion Criteria:

  1. Known hypersensitivity reaction to any component of FCM.
  2. History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
  3. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment.
  4. Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention.
  5. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest).
  6. Current or planned mechanical circulatory support or heart transplantation.
  7. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
  8. Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
  9. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
  10. Active gastrointestinal bleeding.
  11. Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
  12. Inability to return for follow up visits within the necessary windows
  13. Concurrently in a study with investigational product.
  14. No participants with Current COVID-19 Infection into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037931


Contacts
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Contact: James Bambrick 631-379-8831 ext 61818 HEART-FID@luitpold.com
Contact: Michael Dugan, MD 631-687-9246 ext 61812 HEART-FID@luitpold.com

Locations
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United States, Alabama
Advanced Cardiovascular LLC Recruiting
Alexander City, Alabama, United States, 35010
Contact: Sabrina Forbus, RN BSN    256-215-5323    s.forbus.adv@gmail.com   
Principal Investigator: William R Davis, MD         
Advanced Cardiovascular, LLC Recruiting
Auburn, Alabama, United States, 36830
Contact: Sabrina Forbus, RN BSN    334-290-2550    s.forbus.adv@gmail.com   
Principal Investigator: Brian Foley, MD         
IMC/Diagnostic & Medical Clinic Recruiting
Mobile, Alabama, United States, 36604
Contact: Patricia Sullivan    251-435-1210    patricia.sullivan@infirmaryhealth.org   
Principal Investigator: Frank M Lester, MD         
University of South Alabama Recruiting
Mobile, Alabama, United States, 36617
Contact: Cherie Revere, CRNP    251-471-7027    crevere@health.southalabama.edu   
Principal Investigator: Christopher Malozzi, DO         
United States, Alaska
Alaska Heart & Vascular Institute Active, not recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Verde Valley Medical Center Active, not recruiting
Cottonwood, Arizona, United States, 86326
Clinical Research Institute of Arizona, LLC Recruiting
Surprise, Arizona, United States, 85374
Contact: Jamie Foreman    623-223-1580    Jamie.foreman@msp-healthcare.com   
Principal Investigator: Jalal Abbas, MD         
Carondelet Heart and Vascular Institute - Cardiology East Active, not recruiting
Tucson, Arizona, United States, 85710
United States, Arkansas
Sparks Regional Medical Center Recruiting
Fort Smith, Arkansas, United States, 72901
Contact: Brenna Nguyen    479-441-5508    Brenna.nguyen@sparkshealth.com   
Principal Investigator: Abdul-Nasser Adjei, MD         
NEA Baptist Clinic Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Gordon Blake Davis, LPN    870-936-8365    Blake.davis@neabc.com   
Principal Investigator: Dharmendra V Patel, MD         
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Abby Nolan    501-978-3703    Abby.nolen@arheart.com   
Principal Investigator: Michael Huber, MD         
United States, California
Westside Medical Associates of Los Angeles Recruiting
Beverly Hills, California, United States, 90211
Contact: Edith Flores    310-289-5221    edithf@westsidecardio.com   
Principal Investigator: Norman E Lepor, MD         
Harbor-UCLA Medical Center Recruiting
Carson, California, United States, 90509
Contact: Olga Barillas    310-781-3622    olga@labiomed.org   
Principal Investigator: William J French, MD         
Valley Clinical Trials, Inc. Recruiting
Covina, California, United States, 91723
Contact: Lisa Nakatani    626-915-4702    lisa@valleyclinicaltrials.com   
Principal Investigator: Fahed Bitar, MD         
TriWest Research Associates, LLC Active, not recruiting
El Cajon, California, United States, 92020
California Heart Specialists Active, not recruiting
Huntington Beach, California, United States, 92648
First Valley Medical Group Active, not recruiting
Lancaster, California, United States, 93534
Healthcare Partners Affiliation Medical Group Terminated
Long Beach, California, United States, 90806
Axis Clinical Trials Terminated
Los Angeles, California, United States, 90036
St. Joseph Heritage-Healthcare Recruiting
Mission Viejo, California, United States, 92691
Contact: Sonia Cummings    949-364-3612 ext 1210    Sonia.cummings@stjoe.org   
Principal Investigator: Michael Miyamoto, MD         
Radin Cardiovascular Medical Group, Inc. Recruiting
Newport Beach, California, United States, 92663
Contact: Adrian Flores    714-469-0542    adrianflores@macksresearch.com   
Principal Investigator: Michael Radin, M.D.         
Valley Clinical Trials, Inc. Recruiting
Northridge, California, United States, 91325
Contact: Julie Toven    818-280-4220    julie@valleyclinicaltrials.com   
Principal Investigator: Masoud M Azizad, MD         
Pasadena Clinical Research Recruiting
Pasadena, California, United States, 91105
Contact: Julie Toven    818-280-4220 ext 208    julie@valleyclinicaltrials.com   
Principal Investigator: Christopher G Chow, MD         
Eugene Soroka, MD Inc. Active, not recruiting
Port Hueneme, California, United States, 93041
VA San Diego Health Care System Recruiting
San Diego, California, United States, 92161
Contact: Tiffany Hancock    858-642-1129    Tiffany.Hancock@VA.Gov   
Principal Investigator: William F Penny Jr, MD         
Interventional Cardiology Medical Group Recruiting
West Hills, California, United States, 91307
Contact: Michael Fam    818-235-7104    mfam@elegantrd.com   
Principal Investigator: Farhad Rafii, M.D.         
United States, Colorado
South Denver Cardiology Associates, PC Recruiting
Littleton, Colorado, United States, 80120
Contact: Sue Derbyshire, RN, BSN    303-703-2124    sderbyshire@southdenver.com   
Principal Investigator: Ira Dauber, MD         
United States, Connecticut
Danbury Hospital Recruiting
Danbury, Connecticut, United States, 06810
Contact: Akshara Patel    203-739-4990    akshara.patel@nuvancehealth.org   
Principal Investigator: Carol Gemayel-Barra, MD         
Stamford Hospital Active, not recruiting
Stamford, Connecticut, United States, 06904
United States, Delaware
Christiana Care Recruiting
Newark, Delaware, United States, 19718
Contact: Deborah Moore    302-733-4761    dmoore@christianacare.org   
Principal Investigator: Sourin Banerji, MD         
Alfieri Cardiology Active, not recruiting
Wilmington, Delaware, United States, 19803
United States, Florida
Cardiology Associates of South Florida Recruiting
Boynton Beach, Florida, United States, 33472
Contact: Neal Patel    561-351-7822    nealpatel@innovatecrtc.com   
Principal Investigator: Lawrence Weinstein, MD         
Cardiovascular & Vein Center of Florida Recruiting
Bradenton, Florida, United States, 34209
Contact: Erin Ryan, RN    941-792-1717    bateypage@yahoo.com   
Principal Investigator: Eulogio J Sanchez, MD         
Innovative Research of West Florida, Inc. Recruiting
Clearwater, Florida, United States, 33756
Contact: Lori Sheets    727-584-6368    LoriS@innovativeresearch.com   
Principal Investigator: Miguel E Trevino, MD         
Avail Clinical Research, LLC Recruiting
DeLand, Florida, United States, 32720
Contact: Gail Lavine, LPN    386-785-2400    glavine@accelclinical.com   
Principal Investigator: Bruce Rankin, DO         
Riverside Clinical Research Recruiting
Edgewater, Florida, United States, 32132
Contact: Renee Bergin, CRC    386-428-7730    rbergin@riversideclinicalresearch.com   
Principal Investigator: Surya Rao, MD         
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Ricardo Guedes    954-265-4185    rguedes@mhs.net   
Principal Investigator: Ioana Dumitru, MD         
St. Vincent's Healthcare - Riverside Recruiting
Jacksonville, Florida, United States, 32204
Contact: Iris Orengo    904-308-5762    Iris.Orengo@ascension.org   
Principal Investigator: Raguveer Murthy, MD         
UF Health Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Chauncey Smoot, BSN    904-244-2092    Chauncey.smoot@jax.ufl.edu   
Principal Investigator: Francesco Franchi, MD         
St. Vincent's Healthcare - Southside Recruiting Recruiting
Jacksonville, Florida, United States, 32216
Contact: Kayla Vinson    904-308-5761    kayla.vinson@ascension.org   
Principal Investigator: Ambar M Patel, MD         
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Marcia F Dubin, CCRC    904-953-8268    Dubin.marcia@mayo.edu   
Principal Investigator: Shahyar Gharacholou, MD         
Empire Clinical Research, LLC Terminated
Miami Lakes, Florida, United States, 33016
ProLive Medical Research Active, not recruiting
Miami, Florida, United States, 33130
Cordova Research Institute, LLC Recruiting
Miami, Florida, United States, 33155
Contact: Yaquelin Rodriguez    786-631-3890    yrodriguez@cordovari.com   
Principal Investigator: Jesus Rodriguez de la Torre, MD         
Med-Care Research Recruiting
Miami, Florida, United States, 33165
Contact: Daniela Urra    305-221-0660    durra@medcareresearch.com   
Principal Investigator: Felix Chion-Fong, MD         
ITB Research Active, not recruiting
Miami, Florida, United States, 33173
Vista Health Research Recruiting
Miami, Florida, United States, 33176
Contact: Jessica Palacio    786-636-6695    jpalacio@vista-health.org   
Principal Investigator: Antonio Blanco, MD         
Florida Hospital Transplant Institute Active, not recruiting
Orlando, Florida, United States, 32804
Cardiology Partners Clinical Research Institute Recruiting
Palm Beach Gardens, Florida, United States, 33410
Contact: Janine Cacciatore, RN    561-537-4778    janine.cacciatore@cardiologypartnerspl.com   
Principal Investigator: Duccio Baldari, MD         
Springfield Medical Center Recruiting
Panama City, Florida, United States, 32401
Contact: Gulafshan Khan, MD    850-785-9511    wazirgirl5@hotmail.com   
Principal Investigator: Misal Khan, MD         
Broward Research Center Recruiting
Pembroke Pines, Florida, United States, 33024
Contact: Noemy Barberan, CCRP    954-482-4290 ext 403    nbarberan@browardresearchcenter.com   
Principal Investigator: Gladys Andrade, MD         
South Florida Research Solutions, LLC Recruiting
Pembroke Pines, Florida, United States, 33026
Contact: Smelda Ferrin       sferrin@sfresearch.net   
Contact    954-986-3067 ext 1002      
Principal Investigator: Denise Spiller, D.O.         
Cardiology Consultants Recruiting
Pensacola, Florida, United States, 32501
Contact: Bridget Lane, RN, BSN    850-430-7062    Bridget.Lane@bhcpns.org   
Principal Investigator: Brent D Videau, MD         
Avanza Medical Research Center Recruiting
Pensacola, Florida, United States, 32503
Contact: Crystal Crump    850-972-9324 ext 2108    c.crump@avanzaresearch.com   
Principal Investigator: Rohit Amin, MD         
Professional Health Care of Pinellas Recruiting
Saint Petersburg, Florida, United States, 33713
Contact: Christina Kerbaj    727-820-1033    ckerbaj@phcpinellas.com   
Principal Investigator: Fadi E Saba, MD         
Indian River Medical Center Recruiting
Vero Beach, Florida, United States, 32960
Contact: Simone Williamson    772-778-8687    simonemwilliamson@gmail.com   
Principal Investigator: Seth Baker, DO         
Cardiology Partners Clinical Research Institute Recruiting
Wellington, Florida, United States, 33449
Contact: Elizabeth Dagher, RN    561-906-4161    Elizabeth.dagher@cardiologypartnerspl.com   
Principal Investigator: Neerav Shah, MD         
United States, Georgia
University Cardiology Associates, LLC Recruiting
Augusta, Georgia, United States, 30901
Contact: Donna Floyd-Bearden    706-724-2463    DonnaFloyd-Bearden@uh.org   
Principal Investigator: Arthur B Chandler, MD         
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Carol Smith, RN    706-721-9680    csmith@augusta.edu   
Principal Investigator: Neal Weintraub, MD         
Piedmont Heart Institute Fayetteville Recruiting
Fayetteville, Georgia, United States, 30214
Contact: Lorraine Trim    404-605-2982    Lorraine.trim@piedmont.org   
Principal Investigator: Andrew Darlington, D.O.         
Georgia Arrhythmia Consultants and Research Institute Recruiting
Macon, Georgia, United States, 31201
Contact: Angie Buice    478-755-1560    abuice@gacri.com   
Principal Investigator: Felix O Sogade, MD         
Mercer University Recruiting
Macon, Georgia, United States, 31201
Contact: Michelle Damron, RN    478-301-5813    damron_ml@mercer.edu   
Principal Investigator: Hemant Goyal, MD         
Atlanta Vanguard Research Institute Active, not recruiting
Smyrna, Georgia, United States, 30082
United States, Illinois
Mount Sinai Hospital Medical Center - Department of Cardiology Recruiting
Chicago, Illinois, United States, 60608
Contact: Biljana Toshanova    872-222-7380      
Contact       Biljana.toshnova@prismsgrp.com   
Principal Investigator: Sandeep Kholsa, M.D         
Medicoricium, LLC Recruiting
Fairview Heights, Illinois, United States, 62208
Contact: Elizabeth Capasso-Gulve, PA-C    618-222-8900    AHC.01@yahoo.com   
Principal Investigator: Omar Almousalli, MD         
United States, Indiana
Parkview Research Center Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Sue Budzon, RN, CCRC    260-266-5617    Sue.budzon@parkview.com   
Principal Investigator: Roy W Robertson, MD         
Franciscan Physician Network - Indiana Heart Physicians Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Stacey Neese, RN    317-893-1900    Stacey.neese@franciscanalliance.org   
Principal Investigator: Michael Barron, MD         
St. Vincent Medical Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Jenny Ferree    317-338-6666      
Principal Investigator: Ashwin Ravichandran, MD         
Indiana University Health Ball Memorial Hospital, Inc. Active, not recruiting
Muncie, Indiana, United States, 47303
Reid Physician Associates / Reid Health Recruiting
Richmond, Indiana, United States, 47374
Contact: Nancy Fry    765-962-1337 ext 6457    nancy.fry@reidhealth.org   
Principal Investigator: John McGinty, MD         
Beacon Medical Group Advanced Cardiovascular Specialists Recruiting
South Bend, Indiana, United States, 46601
Contact: Toni Riehm, RN    574-647-6584    triehm@beaconhealthsystem.org   
Principal Investigator: John F Kobayashi, MD         
United States, Louisiana
Alexandria Cardiology Clinic Recruiting
Alexandria, Louisiana, United States, 71301
Contact: Crystal DuBois    318-473-4613 ext 227    Crystaldubois39@gmail.com   
Principal Investigator: Naseem Jaffrani, MD         
Heart Clinic of Hammond Recruiting
Hammond, Louisiana, United States, 70403
Contact: Jessica Clavier    985-269-7106    jclavier@theheartclinics.com   
Principal Investigator: Ghiath Mikdadi, MD         
Cardiovascular Institute of the South Active, not recruiting
Houma, Louisiana, United States, 70360
Tulane Heart & Vascular Institute Active, not recruiting
New Orleans, Louisiana, United States, 70112
Ochsner Health System Active, not recruiting
New Orleans, Louisiana, United States, 70121
Louisiana Heart Center Recruiting
Slidell, Louisiana, United States, 70458
Contact: Amy Adams    985-649-2700    Amy.adams@laheart.org   
Principal Investigator: Bruce J Iteld, MD         
United States, Maine
Maine Medical Partners Maine Health Cardiology Recruiting
Scarborough, Maine, United States, 04074
Contact: Brenda Glasgow    207-885-9905    glasgb@mmc.org   
Principal Investigator: Samuel T Coffin, MD         
United States, Maryland
Anne Arundel Health System Research Institute Recruiting
Annapolis, Maryland, United States, 21401
Contact: Ashley Rice, RN    443-481-5868    Arice1@aahs.org   
Principal Investigator: James Welker, DO         
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Tonja Howell    410-601-8461    Tjhowell@lifebridgehealth.org   
Principal Investigator: Jeffrey Banker, MD         
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Philip Maglo, RT-MPH    301-896-3060    Pmaglo1@jhmi.edu   
Principal Investigator: Gregory Kumkumian, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kathryn Hardin    636-368-7932    kmhardin@mgh.harvard.edu   
Principal Investigator: Erin Coglianese, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jenifer Kaufman, RN, MS    617-632-8956    jmkaufma@bidmc.harvard.edu   
Principal Investigator: Marwa Sabe, MD         
NECCR Prima Care Research, LLC Recruiting
Fall River, Massachusetts, United States, 02721
Contact: Linda Francoeur    508-672-7450 ext 22    lfrancoeur@neccr.com   
Principal Investigator: Ehab Sorial, MD         
United States, Michigan
Genesys Regional Medical Center Active, not recruiting
Grand Blanc, Michigan, United States, 48439
Western Michigan University Homer Stryker M.D. School of Medicine Active, not recruiting
Kalamazoo, Michigan, United States, 49008
Michigan CardioVascular Institute at Covenant Medical Center Recruiting
Saginaw, Michigan, United States, 48602
Contact: Angela Grimaldi, RN, BSN    989-583-6372    agrimaldi@mcvi.com   
Principal Investigator: Naveed Akhtar, MD         
United States, Minnesota
Allina Health System, dba Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Stephanie Ebnet    612-863-6286    Stephanie.ebnet@allina.com   
Principal Investigator: Peter Eckman, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sue Milbrandt    507-538-6105    Milbrandt.susan@mayo.edu   
Principal Investigator: Margaret Redfield, MD         
United States, Mississippi
Cardiology Associates Research, LLC Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Kelly Hollis, RN, BSN    662-620-6835    kdhollis@nmhs.net   
Principal Investigator: Barry Bertolet, MD         
United States, Missouri
North Kansas City Hospital Recruiting
North Kansas City, Missouri, United States, 64116
Contact: Dianne Kruger-Sargent    816-691-5373    dianne.kruger-sargent@nkch.org   
Principal Investigator: David M Hahn, MD         
St. Louis Heart & Vascular, PC Recruiting
Saint Louis, Missouri, United States, 63136
Contact: Candace Martin    314-741-0911    cmartin@slhv.com   
Principal Investigator: Gil Vardi, MD         
United States, Nebraska
Nebraska Heart Institute Active, not recruiting
Lincoln, Nebraska, United States, 68526
CHI Health Research Center Active, not recruiting
Omaha, Nebraska, United States, 68124
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Jennifer Robinson    702-383-7842    Jennifer.Robinson@umcsn.com   
Principal Investigator: Chowdhury Ahsan, M.D.         
Red Rock Clinical Research, LLC Active, not recruiting
Las Vegas, Nevada, United States, 89146
United States, New Jersey
Monmouth Cardiology Associates, LLC Recruiting
Eatontown, New Jersey, United States, 07724
Contact: Amy Allfrey    732-807-2170    aallfrey@monmouthcardiology.com   
Principal Investigator: Lance Berger, MD         
Englewood Health Active, not recruiting
Englewood, New Jersey, United States, 07631
Advanced Heart & Vascular Institute of Hunterdon Recruiting
Flemington, New Jersey, United States, 08822
Contact: Robin Enea    908-237-3405    robin.enea@yahoo.com   
Principal Investigator: Andrey Espinoza, MD         
Hackensack University Medical Center Active, not recruiting
Hackensack, New Jersey, United States, 07601
Saint Peter's University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08901
Saint Michael's Medical Center Recruiting
Newark, New Jersey, United States, 07102
Contact: Raymond Monel    973-877-2764    rmonel@primehealthcare.com   
Principal Investigator: Abbas Shehadeh, MD         
Rutgers New Jersey Medical School Active, not recruiting
Newark, New Jersey, United States, 07103
AtlantiCare Regional Medical Center Recruiting
Pomona, New Jersey, United States, 08240
Contact: Jackie White, RN    609-404-7654    Jackie.White@AtlantiCare.org   
Principal Investigator: Vineshkumar Patel, MD         
The Valley Hospital Active, not recruiting
Ridgewood, New Jersey, United States, 07450
Cardio Metabolic Institute Active, not recruiting
Somerset, New Jersey, United States, 08873
Holy Name Medical Center Active, not recruiting
Teaneck, New Jersey, United States, 07666
United States, New York
New York Presbyterian Brooklyn Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Mahmoud Mohamed, MD    718-780-5616    Mam9629@nyp.org   
Principal Investigator: John Heitner, MD         
Trinity Medical WNY, PC Recruiting
Cheektowaga, New York, United States, 14227
Contact: Elizabeth Hejna    716-835-2966    ehejna@buffaloheartgroup.com   
Principal Investigator: Michael J Hong, MD         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Brendon Keith    212-241-3507    Brendon.Keith@mountsinai.org   
Principal Investigator: Anuradha Lala-Trindade, MD         
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Contact: Megan Littleton    585-922-3536    Megan.Littleton@rochesterregional.org   
Principal Investigator: Vishal Parikh, MD Parikh, MD         
Richmond University Medical Center Recruiting
Staten Island, New York, United States, 10310
Contact: Adnan Nasir    718-818-2707    anasir@rumcsi.org   
Principal Investigator: Richard Grodman, MD         
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794-7007
Contact: Pooja Shukla, PhD    631-444-7238      
Principal Investigator: Hal A Skopicki, MD         
Circuit Clinical Recruiting
West Seneca, New York, United States, 14224
Contact: Andrew T Haynes, CCRC    716-341-0051    ahayes@circuitclinical.com   
Principal Investigator: David Avino, D.O.         
Northtowns Cardiology, PLLC Active, not recruiting
Williamsville, New York, United States, 14221
United States, North Carolina
Asheville Cardiology Associates Recruiting
Asheville, North Carolina, United States, 28803
Contact: Amber Hull, RN    828-274-6000 ext 1048777    Amber.Hull@msj.org   
Principal Investigator: Benjamin Trichon, MD         
Duke University Heart Failure Research Recruiting
Durham, North Carolina, United States, 27710
Contact: Jennifer Wilson    919-668-8222    j.wilson@duke.edu   
Principal Investigator: Paul Rosenberg, MD         
Medication Management, LLC Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Lauren Talton    336-763-6968    Lauren.tatlon@emailmm.com   
Principal Investigator: Jagadeesh Ganji, MD         
Wake Forest University Health Sciences Recruiting
High Point, North Carolina, United States, 27262
Contact: Ginger Leonard    336-885-6168    gleonar@wakehealth.edu   
Principal Investigator: Thomas Folk, MD         
Monroe Biomedical Research Recruiting
Monroe, North Carolina, United States, 28112
Contact: Jennifer Norton    704-283-7359    Jennifer.norton@monroeresearch.com   
Principal Investigator: David Smith, MD         
Crossroads Clinical Research, Inc. Recruiting
Mooresville, North Carolina, United States, 28117
Contact: Judith Kennedy    704-360-9310 ext 107    judith.crossroads@yahoo.com   
Principal Investigator: Elmer H Stout, MD         
Pinehurst Medical Clinic, Inc. Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Rebecca Meyer    910-235-3144    rmeyer@pinehurstmedical.com   
Principal Investigator: Patrick Simpson, MD         
NC Heart & Vascular Research Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Patty Gothard    919-784-3413    Patricia.Gothard@unchealth.unc.edu   
Principal Investigator: Christopher Chien, MD         
WakeMed Health and Hospitals Recruiting
Raleigh, North Carolina, United States, 27610
Contact: LaMonica Daniel    919-231-6132 ext 421    LaDaniel@WakeMed.org   
Principal Investigator: Stuart D Russell, MD         
PMG Research of Wilmington Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Marcus Albert    910-815-6108    malbert@pmg-research.com   
Principal Investigator: Matthew J Janik, MD         
United States, North Dakota
Trinity Health Center - Medical Arts Recruiting
Minot, North Dakota, United States, 58701
Contact: Natalie Quam    701-857-2510    Natalie.quam@trinityhealth.org   
Principal Investigator: Samir Turk, MD         
United States, Ohio
Aultman Cardiology Clinical Trials Recruiting
Canton, Ohio, United States, 44710
Contact: Jeannie Archinal, RN    330-363-7277    jeannie.archinal@aultman.com   
Principal Investigator: John Prodafikas, MD         
The MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
Contact: Mary Ann Shella, RN    216-778-3704    mshella@metrohealth.org   
Principal Investigator: Khalil Murad, MD         
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Lauren Ives    216-444-9066    ivesl@ccf.org   
Principal Investigator: Jerry Estep, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Roger Faubel    614-292-5462    Roger.Faubel@osumc.edu   
Principal Investigator: Sitaramesh Emani, MD         
North Ohio Heart Center Recruiting
Elyria, Ohio, United States, 44035
Contact: Judy Fritsch    440-414-9130    Jfritsch@nohc.com   
Principal Investigator: Ademola K Abiose, MD         
North Ohio Heart Center Recruiting
Sandusky, Ohio, United States, 44870
Contact: Karlene Humphrey, RN    440-414-9331    khumphrey@nohc.com   
Principal Investigator: William P McGuinn, MD         
Heart House Research Foundation Recruiting
Springfield, Ohio, United States, 45505
Contact: Teresa Bruner    937-323-1404    Hhrf.tbruner@gmail.com   
Principal Investigator: Sayed MT Rizvi, MD         
United States, Oklahoma
South Oklahoma Heart Research, LLC Recruiting
Oklahoma City, Oklahoma, United States, 73135
Contact: Kay Springer    405-628-6756    kspringer@okheart.com   
Principal Investigator: Naeem Khan Tahirkheli, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Colleen Marchand    215-481-4661    colleen.marchand@jefferson.edu   
Principal Investigator: Donald C Haas, MD         
Geisinger Holy Spirit Cardiology Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Nicole Grassmyer, BSN, RN    717-724-6304    nfgrassmyer@geisinger.edu   
Principal Investigator: Rejesh Dave, MD         
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Lou Anne Kruse, RN, BSN    717-544-1777    lakruse@lghealth.org   
Principal Investigator: Lindsay Castle, DO         
Drexel University Completed
Philadelphia, Pennsylvania, United States, 19102
Hospital of the University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
V.A. Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Eve Kellar, RN    412-360-6230    Eve.kellar@va.gov   
Principal Investigator: Alaa Shalaby, MD         
United States, South Carolina
Prisma Health Recruiting
Columbia, South Carolina, United States, 29203
Contact: Lauren Nixon    803-434-3800 ext 53891    Lauren.Nixon@prismahealth.org   
Principal Investigator: Patrick McCann, MD         
Self Regional Hospital Research Center Recruiting
Greenwood, South Carolina, United States, 29646
Contact: Heather Rich    864-943-2416    Heather.rich@selfmedicalgroup.org   
Principal Investigator: Priya Kumar, MD         
Carolina Heart Specialists Recruiting
Lancaster, South Carolina, United States, 29720
Contact: Emad Ghaly    803-285-2041    Eghaly1@gmail.com   
Principal Investigator: Vipul Shah, MD         
United States, South Dakota
Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc. Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Denice Hockett, RN    605-755-4326    Dhockett2@regionalhealth.org   
Principal Investigator: Alexander Schabauer, MD         
United States, Tennessee
Stern Cardiovascular Foundation Recruiting
Germantown, Tennessee, United States, 38138
Contact: Kay Loyd       Kay.loyd@bmhcc.org   
Contact    901-226-0476      
Principal Investigator: Frank McGrew,III, MD         
Tennova Healthcare-Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Contact: Beth Polk, RN    865-818-7535    Beth.polk@tennova.com   
Principal Investigator: Malcolm T Foster, MD         
Parkway Cardiology Associates, PC Recruiting
Oak Ridge, Tennessee, United States, 37830
Contact: Chasity White, RN    865-482-4078 ext 263    cwhite@pcaheart.com   
Principal Investigator: Milan Sheth, DO         
United States, Texas
Amarillo Hearth Clinical Research Institute, Inc. Recruiting
Amarillo, Texas, United States, 79106
Contact: Leticia Mincher, RN    806-463-2153    lmincher@amarilloheartgroup.com   
Principal Investigator: Alan Chu, MD         
PharmaTex Research Recruiting
Amarillo, Texas, United States, 79106
Contact: Casey Mizer, CRC    806-355-2581    cmizer@ccallp.com   
Principal Investigator: Sammy L Cox, MD         
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Rahel Iwnetu    214-857-1637    rahel.iwnetu@va.gov   
Principal Investigator: Shuaib Abdullah, M.D.         
Cardiovascular Research Institute of Dallas Recruiting
Dallas, Texas, United States, 75231
Contact: Denise Daniel    214-360-0869    ddaniel@civadallas.com   
Principal Investigator: Martin R Berk, MD         
Southwest Family Medicine Associates Recruiting
Dallas, Texas, United States, 75235
Contact: Safia Shaikh    214-393-2940    sshaikh@southwestfamilymed.com   
Principal Investigator: Chrisette Dharma, MD         
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Michelle Clark, RN    214-820-1722    Donna.Clark1@BSWHealth.org   
Principal Investigator: Shelley Hall, MD         
Texas Health Research & Education Institute Active, not recruiting
Fort Worth, Texas, United States, 76104
Texas Heart Institute Recruiting
Houston, Texas, United States, 77030
Contact: Sylvia Carranza    832-355-8524    scarranza@texasheart.org   
Principal Investigator: Reynolds Delgado, MD         
Houston Heart & Vascular Associates Recruiting
Kingwood, Texas, United States, 77339
Contact: Holly Little    281-312-0242    HLhoustonheart@yahoo.com   
Principal Investigator: Raymond Little, MD         
Caprock Cardiac Center Research Institute, Inc. Terminated
Lubbock, Texas, United States, 79410
Angelina Medical Research, LLC Recruiting
Lufkin, Texas, United States, 75904
Contact: Jessica Smith    936-634-0180    jessica@angelinamedicalresearch.com   
Principal Investigator: Terry L Wells, MD         
North Dallas Research Associates Recruiting
McKinney, Texas, United States, 75069
Contact: Irfan Ullah    972-562-2345      
Principal Investigator: Muhammad A Khan, MD, MBA         
North Texas Research Associates Recruiting
McKinney, Texas, United States, 75701
Contact: Ahmed Ladak    214-544-3355    ahmed@ntrarx.com   
Principal Investigator: Faizan Iftikhar, MD         
South Texas Cardiovascular Consultants, PLLC Recruiting
San Antonio, Texas, United States, 78201
Contact: Stephanie Cardenas, LVN    210-635-1690    scardenas@txhearthealth.net   
Principal Investigator: Jamil A Malik, MD         
Baylor Scott & White Medical Center Recruiting
Temple, Texas, United States, 76508
Contact: Margarite Grable    254-724-5861    Margarite.Grable@BSWHealth.org   
Principal Investigator: Lazaros Nikolaidis, MD         
PharmaTex Research Recruiting
Tyler, Texas, United States, 75701
Contact: Holly Cade    903-570-4744    hcade@ccallp.com   
Principal Investigator: Thomas Buzbee, MD         
The University of Texas Health Center at Tyler Active, not recruiting
Tyler, Texas, United States, 75708
Wichita Falls Heart Clinic Recruiting
Wichita Falls, Texas, United States, 76301
Contact: Ciarra Heard    940-264-3216    cheard@wf-heartclinic.net   
Principal Investigator: Vedampattu Ganeshram, MD         
United States, Utah
Advanced Clinical Research/Intermountain Heart Center PC Recruiting
West Jordan, Utah, United States, 84088
Contact: Zac Colton    801-542-8190    zcolton@acr-research.com   
Principal Investigator: Stephen Miller, MD         
United States, Vermont
The University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Marilynn Roth, RN    802-847-4746    marilynn.roth@uvmhealth.org   
Principal Investigator: Peter Van Buren, MD         
United States, Virginia
Stroobants Cardiovascular Center Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Joyce White, MSN    434-200-2799    Joyce.white@centrahealth.com   
Principal Investigator: Brian Schietinger, MD         
Riverside Cardiology Specialists Recruiting
Newport News, Virginia, United States, 23601
Contact: Virginia Barch    757-594-4508    Virginia.barch@rivhs.com   
Principal Investigator: Edward Chu, MD         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jordan Dail, RN    757-388-7511    ejdail@sentara.com   
Principal Investigator: David Baran, M.D.         
VCU Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Laura Johnson    804-628-2452    Laura.h.johnson@vcuhealth.org   
Principal Investigator: Mary Ann Peberdy, MD         
Carilion Medical Center Recruiting
Roanoke, Virginia, United States, 24014
Contact: Christina Bryant    540-526-6701    cdbryant@carilionclinic.org   
Principal Investigator: David Sane, MD         
Selma Medical Associates Recruiting
Winchester, Virginia, United States, 22601
Contact: Peggy Gruenther    540-678-2838    pgruenther@selmamed.com   
Principal Investigator: Philip O' Donnell MD, MD         
United States, Washington
Providence Regional Medical Center Everett Recruiting
Everett, Washington, United States, 98201
Contact: Courtney Nichols    425-261-3544    courtney.nichols@providence.org   
Principal Investigator: Vivek Bhatia, MD         
Swedish Heart & Vascular-Advanced Cardiac Support Program Active, not recruiting
Seattle, Washington, United States, 98122
Providence Sacred Heart Medical Center & Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Lisa Davis, CCRC    509-474-3821    Lisa.Davis2@providence.org   
Principal Investigator: Bryan E Fuhs, MD         
CHI Franciscan Research Center Active, not recruiting
Tacoma, Washington, United States, 98405
Walla Walla Clinic Active, not recruiting
Walla Walla, Washington, United States, 99362
Wenatchee Valley Hospital & Clinics Recruiting
Wenatchee, Washington, United States, 98801
Contact: Eliza Del Rocio Zuniga    509-665-5800    Eliza.Zuniga@confluencehealth.org   
Principal Investigator: Guatum S Nayak, MD         
United States, Wisconsin
Marshfield Clinic Active, not recruiting
Marshfield, Wisconsin, United States, 54449
ProHealth Care Inc / Waukesha Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Rita Shetty    262-928-7637    Rita.Shetty@phci.org   
Principal Investigator: Jagdeep Sabharwal, MD         
Australia, New South Wales
SWSLHD-Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 1871
Contact: Rosa Lee    +61 2 8738 3998    rosa.lee@health.nsw.gov.au   
Principal Investigator: Gayathri Kumarasinghe, MD         
Australia, Queensland
Sunshine Coast University Hospital Recruiting
Birtinya, Queensland, Australia, 4575
Contact: Samantha Wadham    61752023056    Samantha.wadham@health.qld.gov.au   
Principal Investigator: Matthew Marrinan, MD         
Cairns Hospital Recruiting
Cairns, Queensland, Australia, 4870
Contact: Sue Dixon    07 4226 8990    Sue.dixon@health.qld.gov.au   
Principal Investigator: Steven Sutcliffe, MD         
The Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Contact: Suzanne Spencer    +617 3139 4711    Suzanne.spencer@health.qld.gov.au   
Principal Investigator: Yee W Wong, MD         
Core Research Group Recruiting
Milton, Queensland, Australia, 4064
Contact: Hennie Venter    61 7 3876 5688    Hennie.venter@coreresearchgroup.com   
Principal Investigator: David M Colquhoun, MD         
Gold Coast University Hospital Recruiting
Southport, Queensland, Australia, 4215
Contact: Tracey Brumby    0412 982 355    gchcardiologyresearch@health.qld.gov.au   
Principal Investigator: Laurie Howes, MD         
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Adelaide, South Australia, Australia, 5011
Contact: Greer Dymott    +61 8 8222 7907    Greer.dymmott@sa.gov.au   
Principal Investigator: Alicia Chan, MD         
SA Heart Terminated
Ashford, South Australia, Australia, 5035
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Chris Hincks    08 8404 2001    Christine.hincks@sa.gov.au   
Principal Investigator: Carmine De Pasquale, MD         
Lyell McEwin Hospital Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Bernadette Hoffmann    0409665851    Bernadette.hoffmann@sa.gov.au   
Principal Investigator: Alicia Chan, MD         
Australia, Sydney
Heart Lung Clinic Recruiting
Darlinghurst, Sydney, Australia
Contact: Carmen Herrera    +61 02 83823025    Carmen.Herrera@svha.org.au   
Principal Investigator: Prof. Peter Macdonald, MD         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Gaynor Cherry    61 3 61667881    Gaynor.cherry@ths.tas.gov.au   
Principal Investigator: Nathan Dwyer, MD         
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia, 5000
Contact: Stephanie Zrim    08 7074 0000    Stephanie.zrim@sahmri.com   
Principal Investigator: Isuru Ranasinghe, MD         
John Hunter Hospital Recruiting
New Lambton Heights, Australia, 2305
Principal Investigator: Dr. Aaron Sverdlov         
Bulgaria
Multiprofile Hospital for Active Treatment: Department of cardiology Recruiting
Gabrovo, Bulgaria, 5300
Contact: Tota Venkova, MD         
Principal Investigator: Dr. Miroslav Stoyanov         
MHAT Haskovo AD Recruiting
Haskovo, Bulgaria, 6304
Principal Investigator: Ivaylo Vasilev, MD         
MHAT Haskovo AD Recruiting
Haskovo, Bulgaria, 6304
Principal Investigator: Ivaylo Vasilev, M.D         
Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology Recruiting
Lom, Bulgaria, 3600
Principal Investigator: Ivan Efremov, M.D.         
Medical Center Medconsult Pleven OOD Recruiting
Pleven, Bulgaria, 5800
Principal Investigator: Maria Tzekova, M.D., PhD         
Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology Recruiting
Sofia, Bulgaria, 1113
Principal Investigator: Ivan Martinov, M.D.         
Second Medical Center-Sofia, EEOD - Department of Cardiology Recruiting
Sofia, Bulgaria, 1202
Principal Investigator: Katarina Vitliyanova, M.D.         
Second Multiprofile Hospital for Active Treatment Recruiting
Sofia, Bulgaria, 1202
Principal Investigator: Georgi Todorov, M.D         
National Multiprofile Transport Hospital Cardiology Clinic Recruiting
Sofia, Bulgaria, 1233
Principal Investigator: Valentina M Kabakchieva, M.D., Ph.D, FESC         
Medical Center Hera EOOD - Office of Cardiology Recruiting
Sofia, Bulgaria, 1510
Principal Investigator: Valentina Grigorova, M.D.         
Multiprofile Regional Hospital for Active Treatment Recruiting
Veliko Tarnovo, Bulgaria, 5002
Principal Investigator: Haralambi Benov, M.D.         
Canada, Alberta
University of Calbary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Kim Ronak    403-220-8282    kronak@ucalgary.ca   
Principal Investigator: Brian Clarke, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Quentin Kushnerik    780-407-3535    quentin.kushnerik@ahs.ca   
Principal Investigator: Justin Ezekowitz, MBBCh         
South Edmonton Cardiology Consultants Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Contact: Vamshasree Golthi    780-757-1371    vamshasree@gmail.com   
Principal Investigator: Mikael Hanninen, MD         
Royal Alexandria Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Elaine Tabanguil    780-613-5008    elaine.tabanguil@albertahealthservices.ca   
Principal Investigator: Marc Benoit, MD         
Canada, British Columbia
Fraser Clinical Trials Recruiting
New Westminster, British Columbia, Canada, V3L 3W4
Contact: Sandi Thiessen    604.521.4500    sthiessen@fraserclinicaltrials.com   
Principal Investigator: Richard Vandegriend, MD         
SMH Cardiology Clinical Trials Recruiting
Surrey, British Columbia, Canada, V3V 0C6
Contact: Tracy Cleveland    604-584-3720    tracycct@telus.net   
Principal Investigator: Dante Manyari, M.D.         
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Contact: Carol Marchand    604-806-8804    cmarchand1@providencehealth.bc.ca   
Principal Investigator: Mustafa Toma, MD         
Victoria Heart Institute Foundation Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Contact: Georgette Morgen    250-595-1884    gmorgen@vhif.org   
Principal Investigator: Elizabeth Swiggum, MD         
Canada, New Brunswick
G.A. Research Associates, Ltd. Recruiting
Moncton, New Brunswick, Canada
Contact: Katherine Reid    506-852-9865    garesearch@nb.aibn.com   
Principal Investigator: Ronald Bourgeois, MD         
Canada, Newfoundland and Labrador
Health Sciences Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Jill Cole, RN    709-777-6996    jill.cole@easternhealth.ca   
Principal Investigator: Bruce Sussex, MD         
Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Jayne Falkenham, RN    902-473-2732    Jayne.Falkenham@nshealth.ca   
Principal Investigator: Miroslaw Rajda, MD         
Canada, Ontario
Manna Research Inc., Burlington South Recruiting
Burlington, Ontario, Canada, L7R 1A4
Contact: Jessica Wilson    905-662-3303 ext 619    jessica.wilson@lmc.ca   
Principal Investigator: Sudip Datta, MD         
Cambridge Cardiac Care Center Recruiting
Cambridge, Ontario, Canada, N1R 6V6
Contact: Jacqueline Lake    519-624-3511    research@cambridgecardiaccare.com   
Principal Investigator: Shekhar Pandey, MD         
Vizel Cardiac Research Recruiting
Cambridge, Ontario, Canada, N1R 7R1
Contact: Beverly Fox    519-622-0067    bafox@bellnet.ca   
Principal Investigator: Saul Vizel, MD         
London Health Sciences Center (LHSC) Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Sandy Carr, RN    519-663-3728    sandy.carr@lhsc.on.ca   
Principal Investigator: Ryan Davey, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Carlos Fernando    416-864-6060 ext 2886    fernandoc@smh.ca   
Principal Investigator: Gordon Moe, MD         
Sinai Health System - Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Elaine Hsu    416-586-4497    elaine.hsu@sinaihealthsystem.ca   
Principal Investigator: John Parker, MD         
Canada, Quebec
Clinique de Cardiologie de Lévis Terminated
Lévis, Quebec, Canada, G6V 4Z5
Montreal Heart Institute Recruiting
Montréal, Quebec, Canada, H1T 1C8
Contact: Maria Ida Dardes    514-376-3330 ext 4056    mariaida.dardes@icm-mhi.org   
Principal Investigator: Eileen O'Meara, MD         
McGill University Health Centre (MUHC) Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Reza Sahebjamei    514-934-1934 ext 24924    reza.sahebjamei@muhc.mcgill.ca   
Principal Investigator: Nadia S Giannetti, MD         
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval Recruiting
Québec, Quebec, Canada, G1V 4G5
Contact: Audrey Grenier    418-656-8711 ext 5429    audrey.grenier@criucpq.ulaval.ca   
Principal Investigator: Sébastien Bergeron, MD         
CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges Recruiting
Saint-Georges, Quebec, Canada, G5Y 4T8
Contact: Émilie Coté    418-228-2031 ext 37279    emilie.cote.cisssca@sss.gouv.qc.ca   
Principal Investigator: Danielle Dion, MD         
Recherche Medical St-Jerome Inc. Recruiting
Saint-Jérôme, Quebec, Canada, J7Z 5T3
Contact: Yanick Sardin Laframboise    450-431-1020    ysardin@stjerome-medicalresearch.ca   
Principal Investigator: Yves Pesant, MD         
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec Recruiting
Trois-Rivières, Quebec, Canada, G8Z 3R9
Contact: Isabelle Roy    819-697-3333 ext 68393    isabelle_roy_chrtr@ssss.gouv.qc.ca   
Principal Investigator: Ying Tung Sia, MD         
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Sarah Boyd    306-230-3020    sboyd004@outlook.com   
Principal Investigator: Alexander Zhai, MD         
Czechia
Kardiologicka ambulance Recruiting
Chlumec Nad Cidlinou, Czechia, 50353
Principal Investigator: - Martin Wiendl, M.D         
Georgia
JSC Evex Hospitals,Georgia Recruiting
Batumi, Georgia, 6010
Principal Investigator: Giorgi Nikolaishvili, M.D., PhD         
Clinic-LJ Recruiting
Kutaisi, Georgia, 4600
Principal Investigator: Zaza Lominadze, MD         
Aleksandre Aladashvili Clinic LLC Recruiting
Tbilisi, Georgia, 0102
Principal Investigator: Irakli Khintibidze, MD, PhD         
Ltd Israel-Georgian Medical Research Clinic "Helsicore" Recruiting
Tbilisi, Georgia, 0112
Principal Investigator: Nodar Emukhvari         
Ltd Pineo Medical Ecosistem Recruiting
Tbilisi, Georgia, 0114
Principal Investigator: Zurab Klimiashvili, M.D.         
Acad. G. Chapidze Emergency Cardiology Center Recruiting
Tbilisi, Georgia, 0159
Principal Investigator: Vakhtang Chumburidze, M.D., PhD         
Bokhua Memorial Cardiovascular Center Recruiting
Tbilisi, Georgia, 0159
Principal Investigator: Rusudan Agladze, M.D., PhD         
Tbilisi Heart and Vascular Clinic Recruiting
Tbilisi, Georgia, 0159
Principal Investigator: Prof. Tamaz Shaburishvili, MD, PhD         
Ltd TIM- Tbilisi Institute of Medicine Recruiting
Tbilisi, Georgia, 0160
Principal Investigator: Levan Kurashvili, M.D.         
Georgian-Dutch Hospital Recruiting
Tbilisi, Georgia, 0172
Principal Investigator: George Khabeishvili, MD, PhD         
Hungary
Debreceni Egyetem Klinikai Központ Kardiológiai Osztály Recruiting
Debrecen, Hungary, 4032
Principal Investigator: Zoltán Csanádi, MD, PhD, FESC         
Clinexpert Gyöngyös Kft Recruiting
Gyöngyös, Hungary, 3200
Principal Investigator: Annamária Piros         
Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház Recruiting
Harkány, Hungary, 7815
Principal Investigator: Zénó Ajtay, MD, PhD         
Bács-Kiskun Megyei Kórház Kardiológiai Osztály Recruiting
Kecskemet, Hungary, 6000
Principal Investigator: András Nagy, M.D., Ph.D         
Andrea Hornyik, MD Recruiting
Miskolc, Hungary, 3529
Principal Investigator: Andrea Hornyik, MD         
Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika, Recruiting
Pecs, Hungary, 7624
Principal Investigator: Kálmán Tóth, M.D., Ph.D         
Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály Recruiting
Szolnok, Hungary, 5000
Principal Investigator: Béla Herczeg, MD         
Belvárosi Egészségház Kft Recruiting
Zalaegerszeg, Hungary, 8900
Principal Investigator: Géza Lupkovics, MD, PhD         
New Zealand
Wellington Hospital Recruiting
Newton, Wellington, New Zealand, 6021
Contact: Beverley Scott    64 4 918 5728    beverley.scott@ccdhb.org.nz   
Principal Investigator: Scott A Harding, MD         
Totara Clinical Research, Health New Lynn Recruiting
Auckland, New Zealand, 0600
Principal Investigator: Craig King, MB ChB         
North Shore Hospital Recruiting
Auckland, New Zealand, 0622
Contact: Gráinne McAnnalley    +6494868920 ext 43591    Grainne.Mcannalley@waitematadhb.govt.nz   
Principal Investigator: Hamish Hart, MD         
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Contact: Cathrine Patten    64 9 3074949 ext 25848    cathrinep@adhb.govt.nz   
Principal Investigator: Jocelyne Benatar, MD         
Middlemore Hospital Recruiting
Auckland, New Zealand, 2025
Contact: Ruth Cammell    +6421421946    Ruth.Cammell@mmclintrials.nz   
Principal Investigator: Marianne Lund, MD         
Christchurch Heart Institute Recruiting
Christchurch, New Zealand, 8140
Contact: Stephanie Rose    64 03 3786137    stephanie.rose@cdhb.health.nz   
Principal Investigator: Richard Troughton, MD         
Dunedin Hospital Recruiting
Dunedin, New Zealand, 9016
Contact: Mary Blok    64 3 4740999 ext 58084    mary.blok@southerndhb.govt.nz   
Principal Investigator: Gerard T Wilkins, MD         
Hauora Tairāwhiti Department of Cardiology Recruiting
Gisborne, New Zealand, 4010
Principal Investigator: Gerard P Devlin, MB, BCh, BAO, MD, FRACP, FCSAN         
Hawke's Bay Hospital Recruiting
Hastings, New Zealand, 4120
Contact: Diana Schmid    +64 6 8788109    Diana.Schmid@hbdhb.govt.nz   
Principal Investigator: Richard Luke, MD         
Hutt Hospital Recruiting
Lower Hutt, New Zealand, 5010
Contact: Jo Kovacs    +6445872520    Jo-anne.kovacs@huttvalleydhb.org.nz   
Principal Investigator: Timothy O'Meegan, MD         
Nelson Hospital Recruiting
Nelson, New Zealand, 7010
Contact: Petra Crone    +64275209782    Petra.Crone@nmdhb.govt.nz   
Principal Investigator: Tammy Pegg, MD         
Taranaki Base Hospital Recruiting
New Plymouth, New Zealand, 4310
Contact: Carolyn Jackson    64 67536139    Carolyn.jackson@tdhb.org.nz   
Principal Investigator: Ian Ternouth, MD         
Rotorua Hospital Recruiting
Rotorua, New Zealand
Contact: Karen Knight    +64 7 349 7955 ext. 7722    Karen.Knight@Lakesdhb.govt.nz   
Principal Investigator: Dr. Susan De Caigney         
Clinical Horizons NEW ZEALAND LTD Recruiting
Tauranga, New Zealand, 3112
Contact: Tracy Paterson    +64 7 571 1492    tracy@clinicalhorizons.co.nz   
Principal Investigator: Andrew P Corin, MD         
Poland
Biokinetica S.A. Przychodnia Józefów Recruiting
Józefów, Poland, 05-410
Principal Investigator: Monika Tomaszewska-Kiecana,, MD         
1 Wojskowy Szpital Klininiczny w Lublinie Recruiting
Lublin, Poland, 20-049
Principal Investigator: Grzegorz Sobieszek, MD         
Ko-Med Centra Kliniczne Recruiting
Lublin, Poland, 20-362
Principal Investigator: Marzena Janik-Palazzolo, MD         
Szpital Swietej Anny w Miechowie Recruiting
Miechów, Poland, 32-200
Principal Investigator: Maciej Żabówka, MD         
Szpital Świętej Anny w Miechowie Recruiting
Miechów, Poland, 32-200
Principal Investigator: Mariusz Kafara, MD, Ph.D         
Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna Recruiting
Nowy Dwór Mazowiecki, Poland, 05-100
Principal Investigator: Piotr Abramczyk, MD, PhD         
Centrum Szybkiej Diagnostyki Kardiologicznej "Kardiomed" M. Zabówka E. Zabówka Recruiting
Tarnow, Poland, 33-100
Principal Investigator: Maciej Żabówka, MD         
Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej Recruiting
Toruń, Poland, 87-100
Principal Investigator: Grzegorz Skonieczny, MD, PhD         
Uniwersyteckie Centrum Kliniczne Recruiting
Warszawa, Poland, 02-097
Principal Investigator: Zbigniew Gaciong, MD, PhD         
Centrum Medyczne K2J2 Recruiting
Wołomin, Poland, 05-200
Principal Investigator: Sławomir Tymiński         
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego Recruiting
Wrocław, Poland, 50-556
Principal Investigator: Joanna Szachniewicz, MD, PhD         
4th Military Hospital Recruiting
Wrocław, Poland, 50-981
Principal Investigator: Bartosz Krakowiak         
Proximum Centrum Usług Medycznych NZOZ Recruiting
Wrocław, Poland, 53-428
Principal Investigator: Marta Obremska, MD, Ph.D         
Marcin Ogórek, MD, PhD Recruiting
Łódź, Poland, 94-048
Principal Investigator: Marcin Ogórek, MD, PhD         
Russian Federation
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases Recruiting
Kemerovo, Russian Federation, 650002
Principal Investigator: Olga Barbarash, MD, PhD         
State Budgetary Healthcare Institution of Moscow city "Moscow Recruiting
Moscow, Russian Federation, 117292
Principal Investigator: Zhanna Kobalava, MD, PhD         
Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital" Recruiting
Saint Petersburg, Russian Federation, 195257
Principal Investigator: Rostislav Nilk, MD, PhD         
LLC "Scientific Research Center Eco-Safety" Recruiting
Saint Petersburg, Russian Federation, 196143
Principal Investigator: Vasily Vasilyuk, MD, PhD, D.Med.Sci         
Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia Recruiting
Saratov, Russian Federation, 410054
Principal Investigator: Yury Grigorievitch Shvarts, M.D., Ph.D         
Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze Recruiting
St. Petersburg, Russian Federation, 192242
Principal Investigator: Victor Kostenko, MD         
Ukraine
Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway" Recruiting
Vinnytsia, Kyiv, Ukraine, 03049
Principal Investigator: Halyna Myshanych, Myshanych, M.D., Ph.D         
Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center", Recruiting
Ivano-Frankivs'k, Ukraine, 76025
Principal Investigator: Igor Vakaliuk, M.D., Ph.D         
Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center" Recruiting
Ivano-Frankivs'k, Ukraine, 76025
Principal Investigator: Igor Vakaliuk, M.D., Ph.D         
Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department Recruiting
Kharkiv,, Ukraine, 61058
Principal Investigator: Igor Kyrychenko, M.D., Ph.D         
Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department Recruiting
Kharkiv, Ukraine, 61058
Principal Investigator: Igor Kyrychenko, M.D., Ph.D         
City Hospital № 8" of Kharkiv City Council, Cardiology Department №2 Kharkiv Medical Academy of Postgraduate Education, Recruiting
Kharkiv, Ukraine, 61176
Principal Investigator: Vira Tseluyko, M.D., Ph.D         
MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2 Recruiting
Kharkiv, Ukraine, 61176
Principal Investigator: Vira Tseluyko, M.D., Ph.D         
Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council Recruiting
Kryvyi Rih, Ukraine, 50031
Principal Investigator: Larysa Rudik, M.D.         
"Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City Recruiting
Kyiv,, Ukraine, 01601
Principal Investigator: Liudmyla Alieksieieva, M.D.         
Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv Recruiting
Kyiv, Ukraine, 01601
Principal Investigator: Liudmyla Alieksieieva, Alieksieieva, M.D.         
Communal non-profit enterprise Kyiv City Clinical Hospital №1 Dept. of Cardiology Recruiting
Kyiv, Ukraine, 02091
Principal Investigator: Oleksandr Karpenko, M.D., Ph.D         
Communal non-profit enterprise Kyiv City Clinical Hospital №1 Recruiting
Kyiv, Ukraine, 02091
Principal Investigator: Oleksandr Karpenko, M.D., Ph.D         
Kyiv City Clinical Hospital of Emergency Aid, Recruiting
Kyiv, Ukraine, 02166
Principal Investigator: Leonid Rudenko, M.D.         
Kyiv City Clinical Hospital of Emergency Aid Recruiting
Kyiv, Ukraine, 02166
Principal Investigator: Leonid Rudenko, M.D.         
Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway" Recruiting
Kyiv, Ukraine, 03049
Principal Investigator: Halyna Myshanych, M.D., Ph.D         
National Scientific Center Institute of Cardiology of M.D Recruiting
Kyiv, Ukraine, 03680
Principal Investigator: Larysa Mishchenko, MD, PhD         
State Institution "National Scientific Center "Institute of Cardiology of M.D. Recruiting
Kyiv, Ukraine, 03680
Contact: MD. PhD.         
Principal Investigator: Larysa Mishchenko, MD. PhD.         
State Institution "National Scientific Center "Institute of Cardiology of M.D. Recruiting
Kyiv, Ukraine, 03680
Principal Investigator: Larysa Mishchenko, PhD, MS         
State Institution "National Scientific Center "Institute of Cardiology of M.D. Recruiting
Kyiv, Ukraine, 03680
Principal Investigator: Larysa Mishchenko, M.D. PhD, Dr. MS         
Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL" Recruiting
Kyiv, Ukraine, 04050
Principal Investigator: Oksana Reshotko, M.D.         
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Treatment and Diagnostic Cardiology Centre", Recruiting
Lviv,, Ukraine, 79041
Principal Investigator: Andriy Faynyk, M.D., Ph.D         
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Recruiting
Lviv, Ukraine, 79041
Principal Investigator: Andriy Faynyk, M.D., Ph.D         
Vinnytsia Regional Clinical Hospital of Veterans of War, Recruiting
Vinnytsia, Ukraine, 21005
Principal Investigator: Valentyn Maslovskyi, M.D.         
Vinnytsia Regional Clinical Hospital of Veterans of War Recruiting
Vinnytsia, Ukraine, 21005
Principal Investigator: Valentyn Maslovskyi, M.D.         
"Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology" Recruiting
Vinnytsia, Ukraine, 21029
Principal Investigator: Yuriy Mostovoy, MD, PhD, DM         
Communal Non-Commercial Enterprise "Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology" Recruiting
Vinnytsia, Ukraine, 21029
Principal Investigator: Yuriy Mostovoy, MD, PhD, DM         
Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology" Recruiting
Vinnytsia, Ukraine, 21029
Principal Investigator: Yuriy Mostovoy, MD, PhD, DM         
Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology Recruiting
Vinnytsia, Ukraine, 21029
Principal Investigator: Yuriy Mostovoy, MD, PhD, DM         
Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine, Recruiting
Zaporizhzhia, Ukraine, 69063
Principal Investigator: Mykhaylo Kolesnyk, M.D., Ph.D         
Communal Enterprise "Hospital №1" of Zhytomyr City Council Recruiting
Zhytomyr,, Ukraine, 10002
Principal Investigator: Ivan Vyshnyvetskyy, M.D., Ph.D         
Communal Enterprise "Hospital №1" of Zhytomyr City Council Recruiting
Zhytomyr, Ukraine, 10002
Principal Investigator: Ivan Vyshnyvetskyy, M.D., Ph.D         
Sponsors and Collaborators
American Regent, Inc.
Duke Clinical Research Institute
Investigators
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Study Chair: Adrian F Hernandez, MD Duke Clinical Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT03037931    
Other Study ID Numbers: 1VIT15043
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases