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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037931
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : November 16, 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3068 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 2021
Estimated Study Completion Date : June 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.


Layout table for eligibility information
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


Locations
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United States, Alabama
Advanced Cardiovascular LLC
Alexander City, Alabama, United States, 35010
Advanced Cardiovascular, LLC
Auburn, Alabama, United States, 36830
IMC/Diagnostic & Medical Clinic
Mobile, Alabama, United States, 36604
University of South Alabama
Mobile, Alabama, United States, 36617
United States, Alaska
Alaska Heart & Vascular Institute
Anchorage, Alaska, United States, 99508
United States, Arizona
Verde Valley Medical Center
Cottonwood, Arizona, United States, 86326
Clinical Research Institute of Arizona, LLC
Surprise, Arizona, United States, 85374
Carondelet Heart and Vascular Institute - Cardiology East
Tucson, Arizona, United States, 85710
United States, Arkansas
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States, 90211
Harbor-UCLA Medical Center
Carson, California, United States, 90509
Valley Clinical Trials, Inc.
Covina, California, United States, 91723
TriWest Research Associates, LLC
El Cajon, California, United States, 92020
California Heart Specialists
Huntington Beach, California, United States, 92648
First Valley Medical Group
Lancaster, California, United States, 93534
Healthcare Partners Affiliation Medical Group
Long Beach, California, United States, 90806
Axis Clinical Trials
Los Angeles, California, United States, 90036
St. Joseph Heritage-Healthcare
Mission Viejo, California, United States, 92691
Radin Cardiovascular Medical Group, Inc.
Newport Beach, California, United States, 92663
Valley Clinical Trials, Inc.
Northridge, California, United States, 91325
Pasadena Clinical Research
Pasadena, California, United States, 91105
Eugene Soroka, MD Inc.
Port Hueneme, California, United States, 93041
VA San Diego Health Care System
San Diego, California, United States, 92161
Interventional Cardiology Medical Group
West Hills, California, United States, 91307
United States, Colorado
South Denver Cardiology Associates, PC
Littleton, Colorado, United States, 80120
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, Delaware
Christiana Care
Newark, Delaware, United States, 19718
Alfieri Cardiology
Wilmington, Delaware, United States, 19803
United States, Florida
Cardiology Associates of South Florida
Boynton Beach, Florida, United States, 33472
Cardiovascular & Vein Center of Florida
Bradenton, Florida, United States, 34209
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States, 33756
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Riverside Clinical Research
Edgewater, Florida, United States, 32132
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
St. Vincent's Healthcare - Riverside
Jacksonville, Florida, United States, 32204
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
St. Vincent's Healthcare - Southside Recruiting
Jacksonville, Florida, United States, 32216
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Empire Clinical Research, LLC
Miami Lakes, Florida, United States, 33016
ProLive Medical Research
Miami, Florida, United States, 33130
Cordova Research Institute, LLC
Miami, Florida, United States, 33155
Med-Care Research
Miami, Florida, United States, 33165
ITB Research
Miami, Florida, United States, 33173
Vista Health Research
Miami, Florida, United States, 33176
Florida Hospital Transplant Institute
Orlando, Florida, United States, 32804
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, United States, 33410
Springfield Medical Center
Panama City, Florida, United States, 32401
Broward Research Center
Pembroke Pines, Florida, United States, 33024
South Florida Research Solutions, LLC
Pembroke Pines, Florida, United States, 33026
Cardiology Consultants
Pensacola, Florida, United States, 32501
Avanza Medical Research Center
Pensacola, Florida, United States, 32503
Professional Health Care of Pinellas
Saint Petersburg, Florida, United States, 33713
Indian River Medical Center
Vero Beach, Florida, United States, 32960
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States, 33449
United States, Georgia
Piedmont Heart Institute - Athens
Athens, Georgia, United States, 30606
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
University Cardiology Associates, LLC
Augusta, Georgia, United States, 30901
Augusta University
Augusta, Georgia, United States, 30912
Piedmont Heart Institute Fayetteville
Fayetteville, Georgia, United States, 30214
Georgia Arrhythmia Consultants and Research Institute
Macon, Georgia, United States, 31201
Mercer University
Macon, Georgia, United States, 31201
Atlanta Vanguard Research Institute
Smyrna, Georgia, United States, 30082
United States, Idaho
Saint Luke's Boise Medical Center
Boise, Idaho, United States, 83712
United States, Illinois
Mount Sinai Hospital Medical Center - Department of Cardiology
Chicago, Illinois, United States, 60608
Medicoricium, LLC
Fairview Heights, Illinois, United States, 62208
United States, Indiana
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
Franciscan Physician Network - Indiana Heart Physicians
Indianapolis, Indiana, United States, 46237
St. Vincent Medical Group
Indianapolis, Indiana, United States, 46260
Indiana University Health Ball Memorial Hospital, Inc.
Muncie, Indiana, United States, 47303
Reid Physician Associates / Reid Health
Richmond, Indiana, United States, 47374
Beacon Medical Group Advanced Cardiovascular Specialists
South Bend, Indiana, United States, 46601
United States, Louisiana
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States, 71301
Heart Clinic of Hammond
Hammond, Louisiana, United States, 70403
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Tulane Heart & Vascular Institute
New Orleans, Louisiana, United States, 70112
Ochsner Health System
New Orleans, Louisiana, United States, 70121
Louisiana Heart Center
Slidell, Louisiana, United States, 70458
United States, Maine
Maine Medical Partners Maine Health Cardiology
Scarborough, Maine, United States, 04074
United States, Maryland
Anne Arundel Health System Research Institute
Annapolis, Maryland, United States, 21401
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Suburban Hospital
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
NECCR Prima Care Research, LLC
Fall River, Massachusetts, United States, 02721
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, United States, 49008
Michigan CardioVascular Institute at Covenant Medical Center
Saginaw, Michigan, United States, 48602
United States, Minnesota
Allina Health System, dba Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States, 38801
United States, Missouri
North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
St. Louis Heart & Vascular, PC
Saint Louis, Missouri, United States, 63136
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
CHI Health Research Center
Omaha, Nebraska, United States, 68124
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Red Rock Clinical Research, LLC
Las Vegas, Nevada, United States, 89146
United States, New Jersey
Monmouth Cardiology Associates, LLC
Eatontown, New Jersey, United States, 07724
Englewood Health
Englewood, New Jersey, United States, 07631
Advanced Heart & Vascular Institute of Hunterdon
Flemington, New Jersey, United States, 08822
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States, 08240
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Cardio Metabolic Institute
Somerset, New Jersey, United States, 08873
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
United States, New York
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Trinity Medical WNY, PC
Cheektowaga, New York, United States, 14227
Mount Sinai Hospital
New York, New York, United States, 10029
Rochester General Hospital
Rochester, New York, United States, 14621
Richmond University Medical Center
Staten Island, New York, United States, 10310
Stony Brook University Hospital
Stony Brook, New York, United States, 11794-7007
Circuit Clinical
West Seneca, New York, United States, 14224
Northtowns Cardiology, PLLC
Williamsville, New York, United States, 14221
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
Duke University Heart Failure Research
Durham, North Carolina, United States, 27710
Medication Management, LLC
Greensboro, North Carolina, United States, 27401
Wake Forest University Health Sciences
High Point, North Carolina, United States, 27262
Duke Cardiology of Lumberton
Lumberton, North Carolina, United States, 28358
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Crossroads Clinical Research, Inc.
Mooresville, North Carolina, United States, 28117
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, United States, 28374
NC Heart & Vascular Research
Raleigh, North Carolina, United States, 27607
WakeMed Health and Hospitals
Raleigh, North Carolina, United States, 27610
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Trinity Health Center - Medical Arts
Minot, North Dakota, United States, 58701
United States, Ohio
Aultman Cardiology Clinical Trials
Canton, Ohio, United States, 44710
The MetroHealth System
Cleveland, Ohio, United States, 44109
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
North Ohio Heart Center
Elyria, Ohio, United States, 44035
North Ohio Heart Center
Sandusky, Ohio, United States, 44870
Heart House Research Foundation
Springfield, Ohio, United States, 45505
United States, Oklahoma
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States, 73135
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Penn State Health Holy Spirit Medical Center Geisinger - Cardiology
Camp Hill, Pennsylvania, United States, 17011
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
V.A. Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
United States, South Carolina
Prisma Health
Columbia, South Carolina, United States, 29203
Self Regional Hospital Research Center
Greenwood, South Carolina, United States, 29646
Carolina Heart Specialists
Lancaster, South Carolina, United States, 29720
United States, South Dakota
Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
Parkway Cardiology Associates, PC
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Amarillo Hearth Clinical Research Institute, Inc.
Amarillo, Texas, United States, 79106
PharmaTex Research
Amarillo, Texas, United States, 79106
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States, 75231
Southwest Family Medicine Associates
Dallas, Texas, United States, 75235
Baylor University Medical Center
Dallas, Texas, United States, 75246
Texas Health Research & Education Institute
Fort Worth, Texas, United States, 76104
Texas Heart Institute
Houston, Texas, United States, 77030
Houston Heart & Vascular Associates
Kingwood, Texas, United States, 77339
Caprock Cardiac Center Research Institute, Inc.
Lubbock, Texas, United States, 79410
Angelina Medical Research, LLC
Lufkin, Texas, United States, 75904
North Dallas Research Associates
McKinney, Texas, United States, 75069
North Texas Research Associates
McKinney, Texas, United States, 75701
South Texas Cardiovascular Consultants, PLLC
San Antonio, Texas, United States, 78201
Baylor Scott & White Medical Center
Temple, Texas, United States, 76508
PharmaTex Research
Tyler, Texas, United States, 75701
The University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708
Wichita Falls Heart Clinic
Wichita Falls, Texas, United States, 76301
United States, Utah
Advanced Clinical Research/Intermountain Heart Center PC
West Jordan, Utah, United States, 84088
United States, Vermont
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
Stroobants Cardiovascular Center
Lynchburg, Virginia, United States, 24501
Riverside Cardiology Specialists
Newport News, Virginia, United States, 23601
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)
Richmond, Virginia, United States, 23249
VCU Medical Center
Richmond, Virginia, United States, 23298
Carilion Medical Center
Roanoke, Virginia, United States, 24014
Selma Medical Associates
Winchester, Virginia, United States, 22601
United States, Washington
Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
Swedish Heart & Vascular-Advanced Cardiac Support Program
Seattle, Washington, United States, 98122
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States, 99204
CHI Franciscan Research Center
Tacoma, Washington, United States, 98405
Walla Walla Clinic
Walla Walla, Washington, United States, 99362
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
ProHealth Care Inc / Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Australia, New South Wales
SWSLHD-Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Australia, Queensland
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Cairns Hospital
Cairns, Queensland, Australia, 4870
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Core Research Group
Milton, Queensland, Australia, 4064
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Australia, South Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
SA Heart
Ashford, South Australia, Australia, 5035
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Australia, Sydney
Heart Lung Clinic
Darlinghurst, Sydney, Australia
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia
Royal Adelaide Hospital
Adelaide, Australia, 5000
Macquarie University - Clinical Trials Unit
Macquarie Park, Australia, 2109
John Hunter Hospital
New Lambton Heights, Australia, 2305
Epworth HealthCare Clinical Trials
Richmond, Australia, 3121
Bulgaria
MHAT Puls
Blagoevgrad, Bulgaria, 2700
Multiprofile Hospital for Active Treatment: Department of cardiology
Gabrovo, Bulgaria, 5300
MHAT Haskovo AD
Haskovo, Bulgaria, 6304
Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology
Lom, Bulgaria, 3600
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria, 5800
МC Hipokrena
Sevlievo, Bulgaria, 5400
Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology
Sofia, Bulgaria, 1113
Second Medical Center-Sofia, EEOD - Department of Cardiology
Sofia, Bulgaria, 1202
Second Multiprofile Hospital for Active Treatment
Sofia, Bulgaria, 1202
5th City Hospital
Sofia, Bulgaria, 1233
National Multiprofile Transport Hospital Cardiology Clinic
Sofia, Bulgaria, 1233
Medical Center Hera EOOD - Office of Cardiology
Sofia, Bulgaria, 1510
Multiprofile Regional Hospital for Active Treatment
Veliko Tarnovo, Bulgaria, 5002
Medical Center Velingrad 2017" EOOD, Office of Cardiology
Velingrad, Bulgaria, 4600
Canada, Alberta
University of Calbary
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
South Edmonton Cardiology Consultants
Edmonton, Alberta, Canada, T6L 6K3
Royal Alexandria Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
Fraser Clinical Trials
New Westminster, British Columbia, Canada, V3L 3W4
SMH Cardiology Clinical Trials
Surrey, British Columbia, Canada, V3V 0C6
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6E 1M7
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 4R2
Canada, New Brunswick
G.A. Research Associates, Ltd.
Moncton, New Brunswick, Canada
Canada, Newfoundland and Labrador
Health Sciences Centre
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Manna Research Inc., Burlington South
Burlington, Ontario, Canada, L7R 1A4
Cambridge Cardiac Care Center
Cambridge, Ontario, Canada, N1R 6V6
Vizel Cardiac Research
Cambridge, Ontario, Canada, N1R 7R1
London Health Sciences Center (LHSC)
London, Ontario, Canada, N6A 5A5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sinai Health System - Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Clinique de Cardiologie de Lévis
Lévis, Quebec, Canada, G6V 4Z5
Montreal Heart Institute
Montréal, Quebec, Canada, H1T 1C8
McGill University Health Centre (MUHC)
Montréal, Quebec, Canada, H4A 3J1
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, Canada, G1V 4G5
CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
Saint-Georges, Quebec, Canada, G5Y 4T8
Recherche Medical St-Jerome Inc.
Saint-Jérôme, Quebec, Canada, J7Z 5T3
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec
Trois-Rivières, Quebec, Canada, G8Z 3R9
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czechia
Interni kardiologicka klinika FN Brno
Brno, Czechia, 625 00
Kardiologicka ambulance
Chlumec Nad Cidlinou, Czechia, 50353
Centrum preventivní kardiologie, Karlovo nám. 32,
Prague, Czechia, 128 08
Centrum preventivní kardiologie
Prague, Czechia, 128 08
General University Hospital in Prague
Prague, Czechia, 128 08
General University Hospital
Prague, Czechia, 128 08
IKEM-Klinika kardiologie
Prague, Czechia, 140 21
Georgia
JSC Evex Hospitals,Georgia
Batumi, Georgia, 6010
Clinic-LJ
Kutaisi, Georgia, 4600
Aleksandre Aladashvili Clinic LLC
Tbilisi, Georgia, 0102
Ltd Israel-Georgian Medical Research Clinic "Helsicore"
Tbilisi, Georgia, 0112
Ltd Pineo Medical Ecosistem
Tbilisi, Georgia, 0114
Acad. G. Chapidze Emergency Cardiology Center
Tbilisi, Georgia, 0159
Bokhua Memorial Cardiovascular Center
Tbilisi, Georgia, 0159
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, 0159
Ltd TIM- Tbilisi Institute of Medicine
Tbilisi, Georgia, 0160
Georgian-Dutch Hospital
Tbilisi, Georgia, 0172
Hungary
Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai
Budapest, Hungary, 1085
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
Budapest, Hungary, 1122
Debreceni Egyetem Klinikai Központ Kardiológiai Osztály
Debrecen, Hungary, 4032
Clinexpert Gyöngyös Kft
Gyöngyös, Hungary, 3200
Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház
Harkány, Hungary, 7815
Bács-Kiskun Megyei Kórház Kardiológiai Osztály
Kecskemet, Hungary, 6000
Andrea Hornyik, MD
Miskolc, Hungary, 3529
Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,
Pecs, Hungary, 7624
Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály
Szolnok, Hungary, 5000
Belvárosi Egészségház Kft
Zalaegerszeg, Hungary, 8900
Latvia
Daugavpils Regional Hospital
Daugavpils, Latvia, LV5417
Liepajas Regional Hospital
Liepaja, Latvia, LV3414
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV1002
Riga East University hospital clinic Gailezers
Riga, Latvia, LV1038
Lithuania
The Hospital of Lithuanian
Kaunas, Lithuania, 50161
Klaipeda Seaman's Hospital
Klaipėda, Lithuania, 92288
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania, 08661
New Zealand
Wellington Hospital
Newton, Wellington, New Zealand, 6021
Totara Clinical Research, Health New Lynn
Auckland, New Zealand, 0600
North Shore Hospital
Auckland, New Zealand, 0622
Auckland City Hospital
Auckland, New Zealand, 1023
Middlemore Hospital
Auckland, New Zealand, 2025
Christchurch Heart Institute
Christchurch, New Zealand, 8140
Dunedin Hospital
Dunedin, New Zealand, 9016
Hauora Tairāwhiti Department of Cardiology
Gisborne, New Zealand, 4010
Hawke's Bay Hospital
Hastings, New Zealand, 4120
Hutt Hospital
Lower Hutt, New Zealand, 5010
Nelson Hospital
Nelson, New Zealand, 7010
Taranaki Base Hospital
New Plymouth, New Zealand, 4310
Rotorua Hospital
Rotorua, New Zealand
Clinical Horizons NEW ZEALAND LTD
Tauranga, New Zealand, 3112
Poland
Oddział Kardiologii WSzS nr 4
Bytom, Poland, 41-902
Biokinetica S.A. Przychodnia Józefów
Józefów, Poland, 05-410
Centrum Medyczne Linden
Kraków, Poland, 30-394
1 Wojskowy Szpital Klininiczny w Lublinie
Lublin, Poland, 20-049
Ko-Med Centra Kliniczne
Lublin, Poland, 20-362
Szpital Swietej Anny w Miechowie
Miechów, Poland, 32-200
Szpital Świętej Anny w Miechowie
Miechów, Poland, 32-200
Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna
Nowy Dwór Mazowiecki, Poland, 05-100
Zespol Opieki Zdrowotnej
Oława, Poland, 55-200
Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej
Toruń, Poland, 87-100
Uniwersyteckie Centrum Kliniczne
Warszawa, Poland, 02-097
Centrum Medyczne K2J2
Wołomin, Poland, 05-200
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wrocław, Poland, 50-556
4th Military Hospital
Wrocław, Poland, 50-981
Proximum Centrum Usług Medycznych NZOZ
Wrocław, Poland, 53-428
Marcin Ogórek, MD, PhD
Łódź, Poland, 94-048
Russian Federation
Municipal Autonomous Healthcare Institution "City Clinical Hospital #6
Chelyabinsk, Russian Federation, 454017
Municipal Autonomous Healthcare Institution
Chelyabinsk, Russian Federation, 454017
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, Russian Federation, 650002
State Budgetary Healthcare Institution of Moscow city "Moscow
Moscow, Russian Federation, 117292
Private Medical Institution "Euromedservice
Pushkin, Russian Federation, 196603
State Budgetary Institution of Ryazan Region
Ryazan, Russian Federation, 390026
JSC Polyclinic Complex
Saint Petersburg, Russian Federation, 190013
Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital"
Saint Petersburg, Russian Federation, 195257
LLC "Scientific Research Center Eco-Safety"
Saint Petersburg, Russian Federation, 196143
JSC Polyclinic Complex
Saint-Petersburg, Russian Federation, 190013
State Healthcare Institution
Saratov, Russian Federation, 410002
Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia
Saratov, Russian Federation, 410054
Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze
St. Petersburg, Russian Federation, 192242
Saint Petersburg Research Institute of Emergency Medicine
St. Petersburg, Russian Federation, 192242
LLC X7 Clinical Research
St. Petersburg, Russian Federation, 194156
Ukraine
Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"
Ivano-Frankivs'k, Ukraine, 76025
Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department
Kharkiv, Ukraine, 61058
Scientific Medical Complex "University Clinic" of Kharkiv
Kharkiv, Ukraine, 61157
MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2
Kharkiv, Ukraine, 61176
Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council
Kryvyi Rih, Ukraine, 50031
"Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City
Kyiv,, Ukraine, 01601
Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv
Kyiv, Ukraine, 01103
Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv
Kyiv, Ukraine, 01601
Communal non-profit enterprise Kyiv City Clinical Hospital №1
Kyiv, Ukraine, 02091
Kyiv City Clinical Hospital of Emergency Aid,
Kyiv, Ukraine, 02166
Kyiv City Clinical Hospital of Emergency Aid
Kyiv, Ukraine, 02166
Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"
Kyiv, Ukraine, 03049
National Scientific Center Institute of Cardiology of M.D
Kyiv, Ukraine, 03680
State Institution "National Scientific Center "Institute of Cardiology
Kyiv, Ukraine, 03680
Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"
Kyiv, Ukraine, 04050
Medical Centre of LLC
Kyiv, Ukraine, 04050
MNPE "Lviv City Clinical Hospital No.5"
Lviv, Ukraine, 79000
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical
Lviv, Ukraine, 79041
Vinnytsia Regional Clinical Hospital of Veterans of War
Vinnytsia, Ukraine, 21005
"Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology"
Vinnytsia, Ukraine, 21029
Communal Non-Profit Enterprise "City
Zaporizhzhia, Ukraine, 69001
Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,
Zaporizhzhia, Ukraine, 69063
Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
Zaporizhzhia, Ukraine, 69600
Communal Enterprise "Hospital №1" of Zhytomyr City Council
Zhytomyr, Ukraine, 10002
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: November 16, 2021
Last Verified: November 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