Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure
Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria: LVEF less than or equal to 35% New York Heart Association (NYHA) class II, III, or IV CHF diagnosis in the 3 months prior to study entry, with a minimum of 6 weeks of treatment Must be on optimal heart failure therapy according to American Heart Association (AHA), American College of Cardiology (ACC), and Heart Failure Society of America (HFSA) heart failure guidelines, including treatment with angiotensin II converting enzyme inhibitors (ACEI) and beta-blocker therapy, or have documentation justifying why optimal therapy is not being used, including intolerance, contraindication, participant preference, or physician's judgment Must be on stable doses of medications (e.g., beta-blocker, ACEI, and additional medications as listed in the study guidelines) for 6 weeks prior to study entry Must be in stable medical condition and able to begin an exercise program, as determined by study physician Exclusion Criteria: Comorbid disease, behavioral limitations, or other limitations that would interfere with exercise training, or would prevent completion of 1 year of exercise training Pregnant or planning to become pregnant in the year following study entry Major heart event or heart procedure within the 6 weeks prior to study entry Heart procedure or hospitalization for any reason planned in the future Expecting to receive a heart transplant in the 6 months following study entry CHF caused by significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction); if valve replacement has been performed, may not participate for 12 months following the procedure CHF caused by congenital heart disease or obstructive cardiomyopathy Performance of exercise training at regular intervals (more than once per week) at a moderate to vigorous intensity at any time in the 6 weeks prior to study entry Exercise testing results that would prevent safe exercise training, as defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines, including abnormal blood pressure response, early ischemic changes, and unexpected life-threatening arrhythmia Use of fixed-rate pacemakers, pacemakers with inability to attain target heart rates, or automatic implantable cardioverter defibrillator (AICD) devices with heart rate limits set below the target heart rate for exercise training Use of an intracardiac device such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy pacemaker in the 6 months prior to study entry (must demonstrate stability for 6 weeks post-procedure) Primary physician considers placement of an intracardiac device such as an ICD or a cardiac resynchronization therapy pacemaker probable within 6 months of study entry; will be excluded until such device has been placed and 6 weeks of stabilization have passed Participation in another clinical trial that may interfere with study participation, follow-up, or data collection, or that may affect cardiovascular morbidity or mortality
Sites / Locations
- University of Alabama at Birmingham
- Heart Clinic Arkansas
- Memorial Heart Institute
- Ahmanson-University of California Los Angeles
- University of California, Davis Medical Center
- University of California at San Diego Medical Center
- University of Colorado Health Sciences Center
- Heart and Vascular Clinic of Northern Colorado
- Hartford Hospital
- Veterans Affairs Medical Center
- Southwest Florida Heart Group
- University of Florida
- Mayo Clinic
- Morehouse School of Medicine
- Emory University Hospital
- Cardiovascular Associates of Augusta
- Heart and Lung Group of Savannah
- Northwestern University Medical Center
- University of Chicago Hospitals
- Central DuPage Hospital
- The Care Group, LLC
- University of Iowa Hospital and Clinics
- University of Louisville
- Ochsner Clinic Foundation
- University of Maryland
- Johns Hopkins University Medical Center
- Boston Medical Center
- Brigham and Women's Hospital
- Henry Ford Hospital
- Saint John Hospital and Medical Center
- William Beaumont Hospital
- University of Minnesota
- Mayo Clinic
- Mid America Heart Institute-Saint Luke's Hospital
- Washington University School of Medicine
- Glacier View Cardiology, P.C.
- Bryan Lincoln General Hospital
- University of Medicine & Dentistry of New Jersey
- Hackensack University Medical Center
- University of New Mexico
- University of Rochester
- Saint Francis Hospital
- University of North Carolina School of Medicine
- Northeast Medical Center
- Duke University Medical Center
- Wake Forest University School of Medicine
- University of Cincinnati
- University Hospitals of Cleveland
- Davis Heart and Lung Research Institute
- Medical University of Ohio
- University of Oklahoma Health Sciences Center
- Oregon Health & Sciences University
- Geisinger Medical Center
- University of Pennsylvania
- Temple University Hospital
- University of Pittsburgh Medical Center
- Saint Thomas Hospital
- Vanderbilt University Medical Center
- Medical City Dallas Hospital
- Baylor Heart and Vascular Hospital
- LDS Hospital
- Lynchburg General Hospital
- University of Washington Medical Center
- University of Wisconsin Madison
- Aurora Health Care
- University of Calgary
- University of Manitoba Health Sciences Center
- Queen Elizabeth II Health Sciences Center
- Hamilton General Hospital
- London Health Sciences Center
- Saint Michaels Hospital
- Toronto General Hospital
- Montreal Heart Institute
- Laval Hospital
- CHU de Caen
- Hopital Beaujon Cardiologie
- Hopital Henri Mondor-Service de C
- Hopital Broussais
- Centre Cardiologie du Nord
- Hopital Brabois
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
2
1