Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure

Completed · Phase 3

Conditions studied: Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive

In brief

The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).

Key facts

Study ID

NCT00047437

Run by

Duke University

People needed

2331

Starts

2003-04-01

Expected to finish

2008-07-01

Last updated by the study team

2013-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Heart Clinic Arkansas — Little Rock, Arkansas, United States
• Memorial Heart Institute — Long Beach, California, United States
• Ahmanson-University of California Los Angeles — Los Angeles, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• University of California at San Diego Medical Center — San Diego, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Heart and Vascular Clinic of Northern Colorado — Fort Collins, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Veterans Affairs Medical Center — Washington D.C., District of Columbia, United States
• Southwest Florida Heart Group — Fort Myers, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Cardiovascular Associates of Augusta — Augusta, Georgia, United States
• Heart and Lung Group of Savannah — Savannah, Georgia, United States
• Northwestern University Medical Center — Chicago, Illinois, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• Central DuPage Hospital — Winfield, Illinois, United States
• The Care Group, LLC — Indianapolis, Indiana, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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