A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure (COMPARE)
Congestive Heart Failure
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring heart failure
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant female At least 18 years of age at the time informed consent is signed Stable, chronic, mild to severe heart failure as defined as subjects with symptoms of heart failure who do not require IV diuretics, inotropes, or vasodilators or those that require support with a left ventricular assist device Angiotensin converting enzyme inhibitors or angiotensin receptor blockers should be prescribed to all patients with HF due to LV systolic dysfunction with reduced LVEF unless contraindicated or intolerant to use At screening, subject has an LVEF < 40 as measured by 2-D echocardiography Willing to provide written informed consent Exclusion Criteria: On beta-blocker therapy for greater than 42 days prior to consent Acute ischemic coronary event or coronary revascularization (PTCA, CABG, thrombolysis) within 1 week of screening echocardiography Scheduled or expected to be scheduled coronary revascularization within 4 weeks Unstable angina (angina characterized by sudden changes in the severity or length of angina attacks or a decrease in level of exertion that precipitates an episode Uncorrected primary obstructive or severe regurgitant valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathies Uncontrolled ventricular arrhythmias (symptomatic or sustained ventricular arrhythmias not controlled with antiarrhythmic therapy or an implantable defibrillator) Current treatment of calcium channel blockers except for long acting dihydropyridines Current treatment on any Class I or III antiarrhythmic, except amiodarone History of sick sinus syndrome unless a pacemaker is in place Second or third degree heart block unless a pacemaker is in place Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy; or having a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with study medication could provoke bronchospasm Expected biventricular pacemaker placement within 8 months of enrollment Resting systolic blood pressure <90 mmHg (based on the average of 3 readings Resting heart rate <50 beats per minute (bpm) (based on the average of 3 readings) Current decompensated heart failure Elevated liver enzymes (i.e., ALT or AST levels greater than 3 times upper limit of normal) History of drug sensitivity or allergic reaction to alpha or beta-blockers Contraindication or intolerance to beta-blockers Pregnant or lactating women and women planning to become pregnant. NOTE: Female subjects must be post-menopausal (i.e., no menstrual period for a minimum of 6 months prior to screening), surgically sterilized, using a double barrier method contraceptive, or using Depo-Provera or implanted contraceptives for at least one month prior to screening and agree to continue to use the same contraceptive method throughout the study. Use of an investigational drug within 30 days of enrollment Participation in an investigational device trial within 30 days of enrollment Known drug or alcohol abuse 1 year prior to enrollment In the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen Has any systemic disease, including cancer, with reduced life expectancy (<12 months) Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study.
Sites / Locations
- Cardiology Associates
- Mobile Heart Specialists
- Mayo Clinic Arizona
- Scottsdale Cardiovascular Research Institute
- South West Heart
- Inland Heart Doctors Medical Group
- Rancho Los Amigos USC
- William Bowden, DO Private Practice
- Merced Heart Associates
- Sutter Memorial Hospital
- Southern California Cardiology Medical Group, Inc.
- Medvin Clinical Research
- Aurora Denver Cardiology Associates
- Medical Center of the Rockies Foundation
- Bay Area Cardiology
- Clearwater Cardiovascular and Interventional Consultants
- White-Wilson Medical Center, PA
- South Florida International Cardiology Consultants, Inc.
- Palm Beach Cardiology
- Cardiac Disease Specialists, PC
- Harbin Clinic
- North Shore Cardiovascular Research Consortium
- Saint Francis Hospital
- Illinois Heart and Vascular
- HeartCare Midwest
- Rockford Cardiology Research Foundation
- Prairie Cardiovascular Consultants
- The Care Group LLC
- River Cities Cardiology
- Iowa Heart Center
- Mid-America Cardiology
- Via Christi Research, Inc.
- Comprehensive Cardiology Associates
- Cardiovascular Associates
- Louisville Cardiology Medical Group
- One Heart, LLC
- Minnesota Heart Clinic
- Hennepin County Medical Center
- Regions Hospital Cardiology Research
- St. Paul Cardiology
- Cardiology Associates Research, LLC
- Rocky Mountain Heart & Lung
- Diagnostic and Clinical Cardiology
- University of New Mexico
- Albany Associates in Cardiology
- Montefiore Medical Center
- Buffalo Heart Group, LLP
- Long Island Heart Associates
- New York Cardiovascular Associates
- South Bay Cardiovascular Associates
- University of North Carolina
- LeBauer Cardiovascular Research Foundation
- Wake Forest University Baptist Medical Center
- Sterling Research Group Ltd.
- The Lindner Clinical Trial Center
- University Hospital
- Northwest Ohio Cardiology Consultants
- Oklahoma Cardiovascular Research Group
- Samaritan Cardiology
- Blair Medical Associates
- Tri-State Medical Group
- Central Bucks Specialists
- Cardiology Consultants of Philadelphia
- Mid State Medical Service
- Buxmont Cardiology Associates, PC
- Rhode Island Heart Failure Center
- Charleston Cardiology
- South Carolina Heart Center
- Heart Specialists
- Texas Cardiac Center
- Intermountain Medical Center
- Heart Center
- Winchester Medical Center
- Luther Midelfort Mayo Health Systems
- Green Bay HeartCare
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2