Heart Failure Clinical Trial
— RAIDOfficial title:
Late Sodium Current Blockade in High-Risk ICD Patients
Verified date | July 2018 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1012 |
Est. completion date | February 28, 2017 |
Est. primary completion date | February 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 or creatinine clearance <30 ml/min - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | Royal Alexandra Hospital | Edmonton | Alberta |
Canada | Queen's University | Kingston | Ontario |
Canada | McGill University Health Centre | Montreal | Quebec |
Canada | Montreal Heart Institute | Montreal | Quebec |
Canada | IUCPQ | Quebec | |
Canada | CHUS (Sherbrooke University) | Sherbrooke | Quebec |
United States | Abington Medical Specialists | Abington | Pennsylvania |
United States | Georgia Health Sciences University | Augusta | Georgia |
United States | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Tufts-New England Medical Center | Boston | Massachusetts |
United States | Bay Area Cardiology Associates, P.A. | Brandon | Florida |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | Maimonides Medical Center | Brooklyn | New York |
United States | New York Methodist Hospital | Brooklyn | New York |
United States | SUNY Downstate Medical Center | Brooklyn | New York |
United States | Lahey Clinic | Burlington | Massachusetts |
United States | Cooper University Hospital | Camden | New Jersey |
United States | CAMC Institute | Charleston | West Virginia |
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | Cardiovascular Associates Ltd. | Chesapeake | Virginia |
United States | University of Chicago Hospital | Chicago | Illinois |
United States | The Lindner Center for Research & Education | Cincinnati | Ohio |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | The MetroHealth System - Heart and Vascular Dept. | Cleveland | Ohio |
United States | MedStar Southern Maryland Hospital Center | Clinton | Maryland |
United States | University of Colorado Health - MHS | Colorado Springs | Colorado |
United States | University of Missouri | Columbia | Missouri |
United States | Cardiopulmonary Research Science and Technology Inst. | Dallas | Texas |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Doylestown Cardiology Associates - VIAA | Doylestown | Pennsylvania |
United States | Doylestown Health Cardiology/Central Bucks | Doylestown | Pennsylvania |
United States | St. Luke's Hospital Association of Duluth | Duluth | Minnesota |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Durham VA Medical Center | Durham | North Carolina |
United States | Sequoia Hospital | East Palo Alto | California |
United States | Peakview Research Center | Fort Wayne | Indiana |
United States | University of Florida/Cardiovascular Medicine | Gainesville | Florida |
United States | The Stern Cardiovascular Center | Germantown | Tennessee |
United States | Hartford Hospital | Hartford | Connecticut |
United States | LaPorte Hospital | Hobart | Indiana |
United States | Medicus Alliance CRO, Inc | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | University of Florida Health Science Center at Jacksonville | Jacksonville | Florida |
United States | Kansas City Heart Foundation | Kansas City | Missouri |
United States | Watson Clincia Center for Research Inc. | Lakeland | Florida |
United States | Lancaster Heart & Stroke Foundation | Lancaster | Pennsylvania |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | Arkansas Cardiology | Little Rock | Arkansas |
United States | Good Samaritan Hospital | Los Angeles | California |
United States | Georgia Arrhythmia Consultants | Macon | Georgia |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Morristown Memorial Hospital- Gagnon Cardiovascular Institute | Morristown | New Jersey |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Louisiana State University Health Sciences Center- New Orleans | New Orleans | Louisiana |
United States | St. Luke's-Roosevelt Hospital | New York | New York |
United States | Weill Cornell Medical College/New York Presbyterian Hospital | New York | New York |
United States | Florida Hospital | Orlando | Florida |
United States | Huntington Memorial Hospital | Pasadena | California |
United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center-Presbyterian | Pittsburgh | Pennsylvania |
United States | VA Pittsburgh Healthcare Center | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Portland VA Medical Ctr | Portland | Oregon |
United States | Walter Reed NMMC | Portsmouth | Virginia |
United States | Hudson Valley Heart Center | Poughkeepsie | New York |
United States | Wheaton Franciscan All Saints | Racine | Wisconsin |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | The Valley Hospital | Ridgewood | New York |
United States | University of Rochester | Rochester | New York |
United States | William Beaumont Hospital - Royal Oak | Royal Oak | Michigan |
United States | Regional Cardiology Associates | Sacramento | California |
United States | Kootenai Heart Clinics, LLC | Spokane | Washington |
United States | Delta Heart and Medical Clinic | Stockton | California |
United States | Stony Brook University Medical Center, | Stony Brook | New York |
United States | Cardiac Study Center | Tacoma | Washington |
United States | Tallahassee Research Institute, Inc. | Tallahassee | Florida |
United States | The Toledo Hospital/Northwest Ohio Cardiology Consultants | Toledo | Ohio |
United States | University of Arizona | Tucson | Arizona |
United States | Brigham and Women's Cardiovascular Associates | Warwick | Rhode Island |
United States | Washington Electrophysiology/Cardiovascular Research Institute | Washington | District of Columbia |
United States | University of Massachusetts-Worchester | Worcester | Massachusetts |
United States | Lankenau Institute for Medical Research | Wynnewood | Pennsylvania |
United States | Michigan Heart | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Patients Whose First VT/VF Required Antitachycardia Pacing (ATP) | Number of patients whose first VT or VF required antitachycardia pacing (ATP) | 2 years of follow-up on average | |
Other | Number of Patients Whose First VT/VF Required ICD Shock | number of patients whose first VT or VF required ICD shock | 2 years of follow-up on average | |
Primary | Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death | Primary endpoint of the study will be defined as a composite endpoint consisting of Ventricular Tachycardia or Ventricular Fibrillation requiring antitachycardia pacing (ATP) therapy, implantable cardioverter-defibrillator (ICD) shock, or death, whichever occurs first. | 2 years of follow-up on average | |
Secondary | Number of Patients With VT or VF Requiring ICD Shock or Death | Implantable cardioverter-defibrillator (ICD) shock for VT or VF or death, whichever occurs first. | 2 years of follow-up on average | |
Secondary | Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies | Total number of recurrent ICD therapies requiring antitachycardia pacing (ATP) or shock will be analyzed, not just first event | 2 years of follow-up on average | |
Secondary | Number of Patients With First Inappropriate ICD Shock | Number of patients with first inappropriate ICD shock for other reasons than VT or VF | 2 years of follow-up on average | |
Secondary | Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First. | Number of patients with a composite endpoint of cardiovascular hospitalization or death, whichever occurred first. | 2 years of follow-up on average | |
Secondary | Number of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First | Number of patients with a composite endpoint of heart failure hospitalization or death, whichever occurred first. | 2 years of follow-up on average | |
Secondary | Death | Death as a safety endpoint of the trial | 2 years of follow-up on average | |
Secondary | Mean Meters Walked in 6 Minutes | Exercise capacity measured by the 6-minute walk test | 1 year of follow-up | |
Secondary | Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. The scale ranges from 0-100 with lower scores indicating worse outcomes. | 1 year follow-up | |
Secondary | Number of Recurrent Inappropriate ICD Shocks | Number of recurrent inappropriate ICD shocks in all patients combined. | 2 years of follow-up on average |
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