Ranolazine Implantable Cardioverter-Defibrillator Trial (RAID)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Wojciech Zareba, University of Rochester
ClinicalTrials.gov Identifier:
NCT01215253
First received: September 30, 2010
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is routinely prescribed in enrolled patients.


Condition Intervention Phase
Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy
Heart Failure
Drug: Ranolazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Late Sodium Current Blockade in High-Risk ICD Patients

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Ventricular Tachycardia or Ventricular Fibrillation or Death [ Time Frame: 2 years of follow-up on average ] [ Designated as safety issue: Yes ]
    Primary endpoint of the study will be defined as a composite endpoint consisting of Ventricular Tachycardia or Ventricular Fibrillation requiring ATP therapy, ICD shock, or death, whichever occurs first


Secondary Outcome Measures:
  • Cardiac Hospitalization,ICD shock for VT or VF or Death [ Time Frame: 2 years of follow-up on average ] [ Designated as safety issue: Yes ]
    Cardiac hospitalization; ICD shock for VT or VF or death, whichever occurs first.


Estimated Enrollment: 1440
Study Start Date: September 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranolazine
At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at end of first week. For patients on anti-arrhythmic therapy at the time of randomization, their ECG will be checked at end of first week on 500 mg dose and again at end of second week on 1000 mg dose.
Drug: Ranolazine
At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Other Name: Ranexa
Placebo Comparator: Placebo Drug: Ranolazine
At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
Other Name: Ranexa

Detailed Description:

There are limited treatment options for patients at high risk of ventricular arrhythmic events. Beta-blockers alone do not provide enough protection, sotalol has limited effectiveness, and amiodarone although effective in some groups of patients is used infrequently due to its side effects and limitations of a long-term use. Ischemia and cardiomyopathies are associated with a sodium overload of myocardial cells. Late sodium current plays a pivotal role in this process. Sodium overload leads to calcium overload of myocardial cells with consequent increased vulnerability of myocardium to ventricular tachyarrhythmias as well as increased impairment of diastolic relaxation of myocardium thereby augmenting the risk of ischemia and myocardial damage.

Ranolazine is a novel drug with anti-ischemic and antiarrhythmic properties that uniquely blocks late sodium current, decreases intracellular calcium overload, and improves diastolic relaxation of the ventricles. The antiischemic and antiarrhythmic properties of ranolazine might decrease the likelihood of arrhythmic events and improve the clinical course of patients with ventricular arrhythmias.

We designed a randomized double-blind placebo-controlled clinical trial enrolling 1,440 high-risk ICD patients who will be treated with ranolazine or placebo in addition to optimal medical therapy to test the hypothesis that late sodium current blockade contributes to significant reduction in the risk of arrhythmic events or death in high-risk ICD/CRT-D patients.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1,440 high-risk patients with ischemic/nonischemic cardiomyopathy who receive their ICDs as standard of care for primary or secondary prevention of mortality following approved indications for ICD therapy. High-risk patients will be defined as:

Secondary Prevention Patients Subjects with ischemic or nonischemic cardiomyopathy, qualified for or with existing ICD (or CRT-D) after documented VT/VF or cardiac arrest (secondary prevention of mortality). Secondary prevention subjects with existing implants are eligible regardless of when the implant was received (subjects could be recruited from outpatient clinics or from inpatient activity including during re-implant or other procedures).

Primary Prevention Patients

  1. Patients with primary prevention indications for ischemic or non-ischemic cardiomyopathy with EF≤35%, with existing devices (ICD/CRT-D), regardless of when the device was implanted, who have experienced at least ONE episode of VT/VF appropriately treated with ICD therapy (ATP or shock) or had untreated NSVT lasting at least 10 beats with heart rate of at least 170 bpm, documented by electrogram of their implanted device.
  2. Patients with ischemic or non-ischemic cardiomyopathy with EF≤35%, who have been implanted within the last 2 years (initial ICD/CRT-D implants, including upgrades from pacemakers) who have NOT experienced VT/VF treated with ICD therapy (ATP or shock), AND who have ONE of the following additional criteria: BUN≥26 mg/dl or QRS>120ms or Atrial Fibrillation or NSVT documented by ECG/Holter or >500 Ventricular Premature Beats (VPBs)documented in a 24-hour Holter.

    • Stable optimal pharmacologic therapy for the cardiac condition
    • Age: equal to 21 years without upper limit

Exclusion Criteria:

  • Patient receiving first device with coronary artery bypass graft surgery within the last 3 calendar months prior to date consent obtained
  • Patients receiving first device with percutaneous coronary intervention within the last 1 calendar month prior to date consent obtained
  • Patient receiving first device with enzyme-positive myocardial infarction with the past 3 calendar months prior to date consent obtained
  • Patient receiving first device with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
  • Patient in NYHA Class IV
  • Patients receiving prophylactic ablation of ventricular substrate
  • Patients with preexisting QTc prolongation >550ms
  • Patients on strong CYP3A inhibitors (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir and saquinavir and moderate CYP3A inhibitors, including, diltiazem, verapamil, aprepitant, erythromycin, fluconazole and grapefruit juice or grapefruit-containing products.
  • Patients on CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort
  • Patients with inherited arrhythmia disorders such as Brugada's, ARVD, LQTS or hypertrophic cardiomyopathy
  • Patient who is pregnant or plans to become pregnant during the course of the trial (patients at child bearing age who use prescribed pharmaceutical contraceptives could be enrolled)
  • Patient with irreversible brain damage from preexisting cerebral disease
  • Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
  • Patient with chronic renal disease with creatinine >2.5 mg/dl
  • Patient participating in any other clinical trial
  • Patient unwilling or unable to cooperate with the protocol
  • Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
  • Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
  • Patients who are decisionally impaired adults, those of questionable capacity, and those who cannot consent for themselves will not be recruited for this study.
  • Patient unwilling to sign the consent for participation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215253

Contacts
Contact: Suzanne Robertson, PhD 585 273 2244 suzanne.robertson@heart.rochester.edu
Contact: Mary Brown, MS 585 275 8823 Mary.Brown@heart.rochester.edu

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Cardiology Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Stephen Greer, MD    501-227-7596    sgreer@comcast.net   
Contact: Angela Goss    501-227-7596 ext 1211    agoss@arcard.org   
Principal Investigator: Stephen Greer, MD         
United States, California
Sequoia Hospital Recruiting
E. Palo Alto, California, United States, 94303
Contact: Hardwin Mead, MD    650-617-8100    hmead@cmcadocs.com   
Contact: Juanita Fujii    650-363-5262    jfujii@cmcadocs.com   
Principal Investigator: Hardwin Mead, MD         
Good Samaritan Hospital Recruiting
Los Angeles, California, United States, 90017
Contact: David Cannom, MD    213-977-2219    dcannom@lacard.com   
Contact: Young Park    213-977-4175    ypark@goodsam.org   
Principal Investigator: David Cannom, MD         
Huntington Memorial Hospital Recruiting
Pasadena, California, United States, 91105
Contact: Mayer Rashtian, MD    626-397-3877    mrashtianmd@hotmail.com   
Contact: Robin Gemmill    626-397-3872    robin.gemmill@huntingtonhospital.com   
Principal Investigator: Mayer Rashtian, MD         
Regional Cardiology Associates Recruiting
Sacramento, California, United States, 95819
Contact: Shelley Allen    916-453-2626    sallen@rcamd.com   
Contact: Geroid O'Neill    916-736-2323 ext 681    goneill@rcamd.com   
Principal Investigator: Geroid O'Neill, MD         
Delta Heart and Medical Clinic Recruiting
Stockton, California, United States, 95210
Contact: Sujeeth Punnam, MD    209-951-9884    spunnam@deltaheartmed.com   
Contact: Ferlyn Viduya    209-951-9884    ferlyn@deltaheartmed.com   
Principal Investigator: Sujeeth Punnam, MD         
United States, Colorado
University of Colorado Health - MHS Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Mary Olsovsky, MD    719-635-7172    lovepacing@gmail.com   
Contact: Hilary Garcia    719-635-7172    hillary.garcia@uchealth.org   
Principal Investigator: Mary Olsovsky, MD         
United States, Connecticut
Bridgeport Hospital Recruiting
Bridgeport, Connecticut, United States, 06610
Contact: Craig McPherson, MD    203-384-4849    pcmcph@bpthosp.org   
Contact: Tina Cullen    203-384-4849    ntcull@bpthosp.org   
Principal Investigator: Craig McPherson, MD         
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Jeffrey Kluger    860-545-2883    jkluger@harthosp.org   
Contact: Ellen Volponi    860-545-1250    Ellen.volponi@hhchealth.org   
Principal Investigator: Jeffrey Kluger, MD         
Heart Specialists, PC of Southern Connecticut Withdrawn
Shelton, Connecticut, United States, 06484
United States, District of Columbia
Washington Electrophysiology/Cardiovascular Research Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ganesh Venkataraman, MD    202-722-6363    ganesh.s.venkataraman@medstar.net   
Contact: Michelle Deville    202-877-2713    Michelle.Deville@medstar.net   
Principal Investigator: Ganesh Venkataraman, MD         
United States, Florida
Bay Area Cardiology Associates, P.A. Recruiting
Brandon, Florida, United States, 33511
Contact: Christian Perzanowski, MD    813-684-6000 ext 264    christian.perzanowski@gmail.com   
Contact: Trudy Foster    813-684-6000 ext 264    trudy.foster635@gmail.com   
Principal Investigator: Christian Perzanowski, MD         
University of Florida/Cardiovascular Medicine Recruiting
Gainseville, Florida, United States, 32610
Contact: William Miles, MD    352-273-9097    william.miles@medicine.ufl.edu   
Contact: Sarah Long    352-273-8946    sarah.long@medicine.ufl.edu   
Principal Investigator: William Miles, MD         
University of Florida Health Science Center at Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Steve Hsu, MD    904-244-7214    steve.hsu@jax.ufl.edu   
Contact: Marijana Lukovic    904-244-2962    marijana.lukovic@jax.ufl.edu   
Principal Investigator: Steve Hsu, MD         
Watson Clincia Center for Research Inc. Recruiting
Lakeland, Florida, United States, 33805
Contact: Neal Kavesh, MD    863-687-1322    nkavesh@watsonclinic.com   
Contact: Michelle Bass    863-904-2482 ext 4    mbass@watsonclinic.com   
Principal Investigator: Neal Kavesh, MD         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: George Monir, MD    407-303-7556    monirg@gmail.com   
Contact: Leann Goodwin    407-303-8059    leann.goodwin@flhosp.org   
Principal Investigator: George Monir, MD         
Tallahassee Research Institute, Inc. Recruiting
Tallahassee, Florida, United States, 32308
Contact: Marilyn Cox, MD    850-216-0120    macox@southern-med.com   
Contact: Patty Knap    850-431-5024    patty.knap@tmh.org   
Principal Investigator: Marilyn Cox, MD         
United States, Georgia
Georgia Health Sciences University Recruiting
Augusta, Georgia, United States, 30912
Contact: Robert Sorrentino, MD    706-721-7815    rsorrentino@georgiahealth.edu   
Contact: Nancy Starnes    706-721-9680    nstarnes@gru.edu   
Principal Investigator: Robert Sorrentino, MD         
Georgia Arrhythmia Consultants Recruiting
Macon, Georgia, United States, 31201
Contact: Justin Johnson    478-755-1560    jjohnson@gacri.com   
Contact: Daniel Haithcock, MD    478-755-1560    dbhaithcock@hotmail.com   
Principal Investigator: Daniel Haithcock, MD         
United States, Illinois
University of Chicago Hospital Recruiting
Chicago, Illinois, United States, 60637
Contact: Martin Burke, MD    773-702-5988    mburke@medicine.bsd.uchicago.edu   
Contact: Tiffany Hart    773-702-0535    thart@medicine.bsd.uchicago.edu   
Principal Investigator: Martin Burke, MD         
United States, Indiana
LaPorte Hospital Recruiting
Hobart, Indiana, United States, 46342
Contact: Mark Dixon, MD    219-947-6767    mad8224@aol.com   
Contact: Chris Atherton    219-325-4619    catherton@iuhealth.org   
Principal Investigator: Mark Dixon, MD         
IU Health Hospital Network Recruiting
Indianapolis, Indiana, United States, 46202
Contact: William Groh, MD    317-962-0550    wgroh@iupui.edu   
Contact: Judy Foltz    317-274-0981    jfoltz@iu.edu   
Principal Investigator: William Groh, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Trena Thome    319-356-1693    trena-thome@uiowa.edu   
Contact: Alex Mazur, MD    319-351-9159    alexander-mazur@uiowa.edu   
Principal Investigator: Alex Mazur, MD         
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Contact: Gery Tomassoni , MD    859-277-5887    gtomassoni@lexingtoncardio.com   
Contact: Keri Thomas    859-260-6368    keri.thomas@bhsi.com   
Principal Investigator: Geri Tomassoni, MD         
United States, Louisiana
Louisiana State University Health Sciences Center- New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Paul LeLorier, MD    504-568-3546    plelor@lsuhsc.edu   
Contact: Cris Molina    504-568-2349    cmoli1@lsuhsc.edu   
Principal Investigator: Paul Lelorier, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ronald Berger, MD    410-614-2751    rberger@jhmi.edu   
Contact: Michelle Martucci    410-502-0517    mmill148@jhmi.edu   
Principal Investigator: Ronald Berger, MD         
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Stephen Shorofsky, MD    410-328-6056    sshorofs@medicine.umaryland.edu   
Contact: Dawn Ament    410-328-7801    dament1@medicine.umaryland.edu   
Principal Investigator: Stephen Shorofsky, MD         
MedStar Southern Maryland Hospital Center Recruiting
Clinton, Maryland, United States, 20735
Contact: Meseret Deressa    301-877-5583    meseretderessa@southernmarylandhospital.com   
Contact: Ganesh Venkataraman, MD    202-722-6363    ganesh.s.venkataraman@medstar.net   
Principal Investigator: Ganesh Venkataraman, MD         
United States, Massachusetts
Tufts-New England Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Mark Link, MD    617-636-5902    mlink@tuftsmedicalcenter.org   
Contact: Melanie Marshall    617-636-5938    mmarshall@tuftsmedicalcenter.org   
Principal Investigator: Mark Link, MD         
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Jonathan Silver, MD    781-744-8863    jonathan.s.silver@lahey.org   
Contact: Jean Byrne    781-744-1901    Jean.Byrne@lahey.org   
Principal Investigator: Jonathan Silver, MD         
University of Massachusetts-Worchester Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Lawrence Rosenthal, MD    774-443-8931    lawrence.rosenthal@umassmemorial.org   
Contact: Kaethe Giaquinto    508-856-2376/1014    kaethe.giaquinto@umassmed.edu   
Principal Investigator: Lawrence Rosenthal, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Sandy Alexander    313-916-3766    salexan4@hfhs.org   
Contact: Claudio Schuger, MD    313-916-2417    cschuge1@hfhs.org   
Principal Investigator: Claudio Schuger, MD         
William Beaumont Hospital - Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Brian Williamson, MD    248-898-8141    bwilliamson@beaumont.edu   
Contact: Patti Naismith    248-898-8141    PNaismith@beaumont.edu   
Principal Investigator: Brian WIlliamson, MD         
Michigan Heart Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Timothy Shinn, MD    734-712-8000    tshinn@michiganheart.com   
Contact: Gail Brandt    734-712-8386    gbrandt@michiganheart.com   
Principal Investigator: Timothy Shinn, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Scott Sakaguchi, MD    612-625-4401    sakag001@umn.edu   
Contact: Julie Dicken    612-625-9477    dicke022@umn.edu   
Principal Investigator: Scott Sakaguchi, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Scott Kerwin    612-863-8200    Scott.Kerwin@allina.com   
Contact: William Katsiyiannis, MD    612-863-3900    William.Katsiyiannis@allina.com   
Principal Investigator: William Katsiyiannis, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Ernest Quin, MD    601-984-5678    equin@umc.edu   
Contact: Connie Watson    601-984-4242    CNWatson@umc.edu   
Principal Investigator: Ernest Quin, MD         
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Greg Flaker, MD    573-882-2296    flakerg@health.missouri.edu   
Contact: Bonita Baer    573-884-3185    baerbg@health.missouri.edu   
Principal Investigator: Greg Flaker, MD         
Kansas City Heart Foundation Recruiting
Kansas City, Missouri, United States, 64114
Contact: Denetta Nelson    816-523-4525    denetta.nelson@kchf.org   
Contact: John Lee, MD    816 523-5243    jklee888@mac.com   
Principal Investigator: John Lee, MD         
United States, New Jersey
Morristown Memorial Hospital- Gagnon Cardiovascular Institute Recruiting
Morristown, New Jersey, United States, 07962
Contact: Stephen Winters, MD    973-971-4261    stephen.winters@atlantichealth.org   
Contact: Janet Sherer    973-971-8596    Janet.Scherer@atlantichealth.org   
Principal Investigator: Stephen Winters, MD         
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Andrea Job    718-780-3626    alj9016@nyp.org   
Contact: Gioia Turitto, MD    718-780-3626    gturitto@aol.com   
Principal Investigator: Gioia Turitto, MD         
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Adam Budzikowski, MD    718-270-4147    abudzikowski@downstate.edu   
Contact: Justin Nealis, MD    845-544-5164    Nealis.Justin@gmail.com   
Principal Investigator: Adam Budzikowski, MD         
NY Harbor VA Healthcare Center, Brooklyn Campus Recruiting
Brooklyn, New York, United States, 11209
Contact: Nabil El-Sherif    718-836-6600    nelsherif@aol.com   
Contact: Rosemarie Gulino    718-630-3739    Rosemarie.Gulino@va.gov   
Principal Investigator: Nabil El-Sherif, MD         
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Yisachar Greenberg, MD    718-283-7305    ygreenberg@maimonidesmed.org   
Contact: Leat Romano    917-331-7373    lromano@maimonidesmed.org   
Principal Investigator: Yisachar Greenberg, MD         
Weill Cornell Medical College/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: George Thomas, MD    212-746-2655    get2007@med.cornell.edu   
Contact: Bryan Velez de Villa    212-746-4857    brv7001@med.cornell.edu   
Principal Investigator: George Thomas, MD         
St. Luke's-Roosevelt Hospital Recruiting
New York, New York, United States, 10025
Contact: Emad Aziz, MD    212-523-4009    eaziz@chpnet.org   
Contact: Ammy Malinay    212-523-3281    aalburo@chpnet.org   
Principal Investigator: Emad Aziz, MD         
Hudson Valley Heart Center Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Sankar Varanasi, MD, FACC    845-473-1188    snvaranasi@hvheartcenter.com   
Contact: Pramila Krumholtz    845-473-1188 ext 1197    pkrumholtz@hvheartcenter.com   
Principal Investigator: Sankar Varanasi, MD, FACC         
The Valley Hospital Recruiting
Ridgewood, New York, United States, 07450
Contact: Dan Musat, MD    201-447-8453    musada@valleyhealth.com   
Contact: DeAnna Kearney    201-447-8453    dkearne@valleyhealth.com   
Principal Investigator: Dan Musat, MD         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Laura Wing    585-273-1652    laura_wing@urmc.rochester.edu   
Contact: Mehmet Aktas, MD    585-275-4775    mehmet_aktas@urmc.rochester.edu   
Principal Investigator: Mehmet Aktas, MD         
Stony Brook University Medical Center, Recruiting
Stony Brook, New York, United States, 11794
Contact: Eric J Rashba, MD    631-444-3904    erashba@notes.cc.sunysb.edu   
Contact: Alyssa Lanz    631-444-8417    alyssa.lanz@stonybrookmedicine.edu   
Principal Investigator: Eric J Rasha, MD         
United States, North Carolina
Durham VA Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Brett Atwater, MD    919-286-0411 ext 5222    brett.atwater@duke.edu   
Contact: Kathy Aristy    919-286-0411 ext 5222    Kathy.Aristy@va.gov   
Principal Investigator: Brett Atwater, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jonathan Piccini, MD    919-668-8067    jonathan.piccini@duke.edu   
Contact: Mary Hill    919-681-7293    mary.hill@duke.edu   
Principal Investigator: Jonathan Piccini, MD         
United States, Ohio
The Lindner Center for Research & Education Recruiting
Cincinnati, Ohio, United States, 45219
Contact: David White    513-585-2198    david.white@thechristhospital.com   
Contact: Eugene Chung, MD    513-585-1777    chunge@ohioheart.org   
Principal Investigator: Eugene Chung, MD         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Mehran Attari, MD    513-558-4272    Attarim@ucmail.uc.edu   
Contact: Carol Knochelmann    513-558-3016    carol.knochelmann@uc.edu   
Principal Investigator: Mehran Attari, MD         
The MetroHealth System - Heart and Vascular Dept. Recruiting
Cleveland, Ohio, United States, 44109
Contact: Ohad Ziv, MD    216-778-7398    oziv@metrohealth.org   
Contact: Pete Leo    216 778 2714    pleo@metrohealth.org   
Principal Investigator: Ohad Ziv, MD         
The Toledo Hospital/Northwest Ohio Cardiology Consultants Recruiting
Toledo, Ohio, United States, 43615
Contact: Diane Philip    419-842-3090    Diane.Philip@ProMedica.org   
Contact: Kamala Tamirisa, MD    419-842-3000    kamala.tamirisa@yahoo.com   
Principal Investigator: Tamala Tamirisa, MD         
United States, Oregon
Portland VA Medical Ctr Recruiting
Portland, Oregon, United States, 97239
Contact: Merritt Raitt, MD    503-220-8262 ext 57571    merritt.raitt@va.gov   
Contact: Tera Johnston    503-220-8262 ext 57546    tera.johnston@va.gov   
Principal Investigator: Merritt Raitt, MD         
United States, Pennsylvania
Abington Medical Specialists Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Charles Gottlieb, MD    215-517-1027    cdgottlieb@aol.com   
Contact: Matthew Dreese    215-481-4193    mdreese@amh.org   
Principal Investigator: Charles Gottlieb, MD         
Central Bucks Cardiology Recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Donna Taylor    215-345-1900 ext 300    dtaylor@centralbuckscardiology.com   
Contact: Stephen Sloan, MD    215-345-1900 ext 300    sbsloan@gmail.com   
Principal Investigator: Stephen Sloan, MD         
Doylestown Cardiology Associates - VIAA Recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Renee Sangrigoli , MD    215-345-6050    rsangmd@aol.com   
Contact: Linda Schwarz    215-933-0053    lschwarz@cbspecialists.com   
Principal Investigator: Renee Sangrigoli, MD         
Lancaster Heart & Stroke Foundation Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Seth Worley, MD    717-290-6681    seth@mcworley.com   
Contact: Deborah Ramsey    717-290-6681 ext 202    dramsey@lancasterheart.org   
Principal Investigator: Seth Worley, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Barbara Gallagher    215-955-8184    barbara.gallagher@jefferson.edu   
Contact: Arnold Greenspon, MD    215-955-5050    arnold.greenspon@jefferson.edu   
Principal Investigator: Arnold Greenspon, MD         
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Steven Kutalek, MD    215-762-3457    skutalek@drexelmed.edu   
Contact: Shawn Cone    215-762-6557    shawn.cone@drexelmed.edu   
Principal Investigator: Steven Kutalek, MD         
University of Pittsburgh Medical Center-Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Samir Saba, MD    412-647-6272    sabas@upmc.edu   
Contact: Kimberly Veltre    412-864-1240    veltrek@upmc.edu   
Principal Investigator: Samir Saba, MD         
VA Pittsburgh Healthcare Center Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Alaa Shalaby, MD    412-360-6191    Alaa.Shalaby@VA.gov   
Contact: Alanna Caffas    412-360-3866    Alanna.Caffas@va.gov   
Principal Investigator: Alaa Shalaby, MD         
Lankenau Institute for Medical Research Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Douglas Esberg, MD    610-649-6980    EsbergD@MLHS.org   
Contact: Nancy Britton    484-476-8578    brittonn@mlhs.org   
Principal Investigator: Douglas Esberg, MD         
United States, Tennessee
The Stern Cardiovascular Center Recruiting
Germantown, Tennessee, United States, 38138
Contact: Frank McGrew, MD    901-271-1000    Frank.mcgrew@sterncardio.com   
Contact: Terry Howard    901-271-4164    terry.howard@sterncardio.com   
Principal Investigator: Frank McGrew, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Walter Clair, MD    615-396-7537    walter.clair@vanderbilt.edu   
Contact: Sherry Bowman    615-936-0061    sherry.bowman@vanderbilt.edu   
Principal Investigator: Walter Clair, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal    512-458-9410    dscardinal@austinheartbeat.com   
Contact: Andrea Natale, MD    512-458-9410    dr.natale@gmail.com   
Principal Investigator: Andrea Natale, MD         
Cardiopulmonary Research Science and Technology Inst. Recruiting
Dallas, Texas, United States, 75230
Contact: Cecile Mahoney    972-566-5617    cmahoney@crsti.org   
Contact: Jodie Hurwitz, MD    972-566-6820    jhurwitz@nthc.com   
Principal Investigator: Jodie Hurwitz, MD         
Medicus Alliance CRO, Inc Terminated
Houston, Texas, United States, 77090
Trinity Clinic Recruiting
Tyler, Texas, United States, 75701
Contact: Stanislav Weiner, MD    903-531-5166    weiners@tmfhs.org   
Contact: Carol Cushman    903-510-8846    cushmac@tmfhs.org   
Principal Investigator: Stanislav Weiner, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: John DiMarco, MD    434-924-2031    jpd4h@virginia.edu   
Contact: Alyssa Curmassi    434-243-0046    aac2c@hscmail.mcc.virginia.edu   
Principal Investigator: John DiMarco, MD         
Cardiovascular Associates Ltd. Recruiting
Chesapeake, Virginia, United States, 23320
Contact: Ian Woollett, MD    757-547-9294    iwoollett@cval.org   
Contact: Jean Goosmann    757-547-9294    JGoosmann@cval.org   
Principal Investigator: Ian Woollett, MD         
Walter Reed NMMC Recruiting
Portsmouth, Virginia, United States, 20889
Contact: Linda Huffer, MD    301-295-0390    linda.l.huffer@health.mil   
Contact: Michele Young    301-295-2193    michele.k.young@health.mil   
Principal Investigator: Linda Huffer, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Contact: Kenneth Ellenbogen, MD    804-828-7565    kellenbogen@mcvh-vcu.edu   
Contact: Kim Hall    804-828-4700    khall@vcu.edu   
Principal Investigator: Kenneth Ellenbogen, MD         
United States, Washington
Kootenai Heart Clinics, LLC Recruiting
Spokane, Washington, United States, 99204
Contact: Timothy Lessmeier, MD    509-838-7711    timothylessmeier@hcnw.com   
Contact: Kelli Kuykendall    509-838-1955 ext 324    kellikuykendall@hcnw.com   
Principal Investigator: Timothy Lessmeier, MD         
Cardiac Study Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Tariq Salam, MD    253-572-7320    drsalam@cardiacstudycenter.com   
Contact: Kathleen Marks    253-572-7320 ext 3030    KathyMarks@cardiacstudycenter.com   
Principal Investigator: Tariq Salam, MD         
United States, West Virginia
CAMC Institute Recruiting
Charleston, West Virginia, United States, 25304
Contact: Jessica Parker    304-388-9996    jessica.parker@camc.org   
Contact: Brett Faulknier, MD    304-347-1204    bfaulknier@hsc.wvu.edu   
Principal Investigator: Brett Faulknier, MD         
United States, Wisconsin
Marshfield Clinic Terminated
Marshfield, Wisconsin, United States, 54449
Aurora St. Luke's Medical Center Terminated
Milwaukee, Wisconsin, United States, 53215
Wheaton Franciscan All Saints Recruiting
Racine, Wisconsin, United States, 53402
Contact: Anthony Alonge    262-687-8177    Anthony.Alonge@wfhc.org   
Contact: Margot Vloka, MD    262-687-8208    mvloka@aol.com   
Principal Investigator: Margot Vloka, MD         
ProHealth Care, Inc Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Katie Weis    262-928-7637    kathryn.weis@phci.org   
Contact: Vicken Vorperian, MD    262-928-7637    vrvorper@gmail.com   
Principal Investigator: Vicken Vorperian, MD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Wojciech Zareba, MD PhD University of Rochester
  More Information

No publications provided

Responsible Party: Wojciech Zareba, MD PhD, University of Rochester
ClinicalTrials.gov Identifier: NCT01215253     History of Changes
Other Study ID Numbers: U01HL096607
Study First Received: September 30, 2010
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Sudden Death
Ranolazine
Heart failure
Ventricular tachycardia
Ventricular fibrillation
Implantable cardioverter-defibrillator

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014