Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure
- Conditions
- Cardiovascular DiseasesHeart DiseasesHeart Failure, Congestive
- Interventions
- Behavioral: Supervised Exercise Training Program
- Registration Number
- NCT00047437
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).
- Detailed Description
BACKGROUND:
CHF affects approximately five million Americans and is the number one cause of hospital admission in individuals over the age of 65. Although exercise training improves several clinical measures in individuals with CHF (e.g., peak VO2, heart rate variability, and plasma norepinephrine levels), it is not known whether exercise training reduces mortality in individuals with CHF.
DESIGN NARRATIVE:
This multicenter randomized study will determine if exercise training reduces mortality and hospitalization rates in individuals with moderate to severe CHF. The secondary objective is to evaluate whether an exercise program designed for individuals with CHF improves quality of life and functioning, is economically advantageous, and prevents medical complications.
Three thousand individuals with moderate to severe CHF will be randomly assigned to either standard medical therapy and education, or standard medical therapy and education plus a supervised exercise training program. The exercise training will include 36 supervised clinic-based training sessions followed by home-based exercise and periodic supervised sessions for reinforcement. Participants assigned to the supervised exercise training program will use either a treadmill or stationary bicycle, which will be provided for them.
Recruitment Status: As of November 9, 2006, HF-ACTION has enrolled 2180 subjects and will conclude enrollment at the end of February, 2007, with an anticipated enrollment of approximately 2300 subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2331
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Supervised Exercise Training Program -
- Primary Outcome Measures
Name Time Method Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) Measured as events occur during the lifespan of the trial.
- Secondary Outcome Measures
Name Time Method Changes in peak VO2 Measured at 3 months, 12 months, and 24 months. Changes in VE/VCO2 slope Measured at 3 months, 12 months, and 24 months. Heart rate at a submaximal work load defined as the end of the exercise test's second stage Measured at 3 months, 12 months, and 24 months. Changes in 6-minute walk (measured at Month 3 and Year 1) Measured at 3 months, 12 months, 24 months, 36 months, and at end of study. Composite of cardiovascular mortality and cardiovascular hospitalization rates Measured as events occur during the life of the trial. Composite of cardiovascular mortality and CHF hospitalization rates Measured as events occur during the life of the trial. All-cause mortality rates Measured as events occur during the life of the trial. Cardiovascular mortality rates Measured as events occur during the life of the trial. All-cause hospitalization rates Measured as events occur during the life of the trial. CHF hospitalization rates Measured as events occur during the life of the trial. Heart attack rates Measured as events occur during the life of the trial. Worsening CHF event rates Measured as events occur during the life of the trial. Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates Measured as events occur during the life of the trial. Cost Measured throughout the life of the trial. Quality of life Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study
Trial Locations
- Locations (79)
University of Maryland
🇺🇸Baltimore, Maryland, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Northwestern University Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Glacier View Cardiology, P.C.
🇺🇸Kalispell, Montana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mid America Heart Institute-Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of North Carolina School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Manitoba Health Sciences Center
🇨🇦Winnipeg, Manitoba, Canada
Saint Michaels Hospital
🇨🇦Toronto, Ontario, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Lynchburg General Hospital
🇺🇸Lynchburg, Virginia, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Northeast Medical Center
🇺🇸Concord, North Carolina, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Saint Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Medical University of Ohio
🇺🇸Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Bryan Lincoln General Hospital
🇺🇸Lincoln, Nebraska, United States
Hackensack University Medical Center
🇺🇸Westwood, New Jersey, United States
Davis Heart and Lung Research Institute
🇺🇸Columbus, Ohio, United States
Saint Francis Hospital
🇺🇸Roslyn, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Memorial Heart Institute
🇺🇸Long Beach, California, United States
Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Ahmanson-University of California Los Angeles
🇺🇸Los Angeles, California, United States
University of California at San Diego Medical Center
🇺🇸San Diego, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, 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
Veterans Affairs Medical Center
🇺🇸Washington, District of Columbia, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Southwest Florida Heart Group
🇺🇸Fort Myers, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Florida
🇺🇸Gainesville, 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
The Care Group, LLC
🇺🇸Indianapolis, Indiana, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
Johns Hopkins University Medical Center
🇺🇸Baltimore, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Saint John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Oregon Health & Sciences University
🇺🇸Portland, Oregon, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
University of Wisconsin Madison
🇺🇸Madison, Wisconsin, United States
Aurora Health Care
🇺🇸Milwaukee, Wisconsin, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Queen Elizabeth II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
Laval Hospital
🇨🇦Sainte Foy, Quebec, Canada
Hopital Beaujon Cardiologie
🇫🇷Clichy, France
CHU de Caen
🇫🇷Caen, France
Hopital Henri Mondor-Service de C
🇫🇷Creteil, France
Hopital Broussais
🇫🇷Paris, France
Centre Cardiologie du Nord
🇫🇷Saint Denis, France
Hopital Brabois
🇫🇷Vandoeuvre Les Nancy, France
University of Medicine & Dentistry of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States