Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00047437

Purpose

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

Condition	Intervention	Phase
Cardiovascular Diseases Heart Diseases Heart Failure, Congestive	Behavioral: Supervised Exercise Training Program	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Heart Diseases Heart Failure

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) [ Time Frame: Measured as events occur during the lifespan of the trial. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in peak VO2 [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
Changes in VE/VCO2 slope [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
Heart rate at a submaximal work load defined as the end of the exercise test's second stage [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
Changes in 6-minute walk (measured at Month 3 and Year 1) [ Time Frame: Measured at 3 months, 12 months, 24 months, 36 months, and at end of study. ] [ Designated as safety issue: No ]
Composite of cardiovascular mortality and cardiovascular hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
Composite of cardiovascular mortality and CHF hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
All-cause mortality rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
Cardiovascular mortality rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
All-cause hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
CHF hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
Heart attack rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
Worsening CHF event rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
Cost [ Time Frame: Measured throughout the life of the trial. ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study ] [ Designated as safety issue: No ]

Enrollment:	2331
Study Start Date:	April 2003
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator	Behavioral: Supervised Exercise Training Program Exercise 30 minutes minimum three times per week.
1: No Intervention

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047437

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Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Heart Clinic Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Ahmanson-University of California Los Angeles
Los Angeles, California, United States, 90095
University of California at San Diego Medical Center
San Diego, California, United States, 92103
Memorial Heart Institute
Long Beach, California, United States, 90806
University of California, Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
Heart and Vascular Clinic of Northern Colorado
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, District of Columbia
Veterans Affairs Medical Center
Washington, District of Columbia, United States, 20422
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32216
University of Florida
Gainesville, Florida, United States, 32610
Southwest Florida Heart Group
Fort Myers, Florida, United States, 33919
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
Heart and Lung Group of Savannah
Savannah, Georgia, United States, 31405
Cardiovascular Associates of Augusta
Augusta, Georgia, United States, 30901
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
The Care Group, LLC
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242-1081
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40292
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins University Medical Center
Baltimore, Maryland, United States, 21287
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120-1613
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Mid America Heart Institute-Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Montana
Glacier View Cardiology, P.C.
Kalispell, Montana, United States, 59901
United States, Nebraska
Bryan Lincoln General Hospital
Lincoln, Nebraska, United States, 68516
United States, New Jersey
University of Medicine & Dentistry of New Jersey
New Brunswick, New Jersey, United States, 08901
Hackensack University Medical Center
Westwood, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131-0001
United States, New York
University of Rochester
Rochester, New York, United States, 14624
Saint Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 17517
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Northeast Medical Center
Concord, North Carolina, United States, 28025
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0542
Medical University of Ohio
Toledo, Ohio, United States, 43614-2598
Davis Heart and Lung Research Institute
Columbus, Ohio, United States, 43210-1252
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, Tennessee
Saint Thomas Hospital
Nashville, Tennessee, United States, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75426
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Lynchburg General Hospital
Lynchburg, Virginia, United States, 24501
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6310
United States, Wisconsin
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
Aurora Health Care
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Canada, Manitoba
University of Manitoba Health Sciences Center
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3K6A3
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A 4G5
Saint Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Toronto General Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1N6
Laval Hospital
Sainte Foy, Quebec, Canada, G1V 4G5
France
Hopital Brabois
Vandoeuvre Les Nancy, France, 54500
Hopital Henri Mondor-Service de C
Creteil, France, 94010
CHU de Caen
Caen, France, 14000
Hopital Beaujon Cardiologie
Clichy, France, 92110
Centre Cardiologie du Nord
Saint Denis, France, 93200
Hopital Broussais
Paris, France, 75014

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Chair:	Christopher M. O'Connor	Duke University
Study Chair:	David J. Whellan	Jefferson Medical College of Thomas Jefferson University

Responsible Party:	Duke Clinical Research Institute at Duke University Medical Center ( Christopher O'Connor )
Study ID Numbers:	149, U01 HL63747, U01 HL64250, U01 HL64257, U01 HL64264, U01 HL64265, U01 HL66461, U01 HL66482, U01 HL66491, U01 HL66494, U01 HL66497, U01 HL66501, U01 HL68973, U01 HL68980
Study First Received:	October 3, 2002
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00047437 History of Changes
Health Authority:	United States: Federal Government