Clinical trial NCT00047437: Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure
Official title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2002-10-04
Enrollment: 2331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3)
timeFrame: Measured as events occur during the lifespan of the trial.
Secondary outcomes:
measure: Changes in peak VO2
timeFrame: Measured at 3 months, 12 months, and 24 months.
measure: Changes in VE/VCO2 slope
timeFrame: Measured at 3 months, 12 months, and 24 months.
measure: Heart rate at a submaximal work load defined as the end of the exercise test's second stage
timeFrame: Measured at 3 months, 12 months, and 24 months.
measure: Changes in 6-minute walk (measured at Month 3 and Year 1)
timeFrame: Measured at 3 months, 12 months, 24 months, 36 months, and at end of study.
measure: Composite of cardiovascular mortality and cardiovascular hospitalization rates
timeFrame: Measured as events occur during the life of the trial.
measure: Composite of cardiovascular mortality and CHF hospitalization rates
timeFrame: Measured as events occur during the life of the trial.
measure: All-cause mortality rates
timeFrame: Measured as events occur during the life of the trial.
measure: Cardiovascular mortality rates
timeFrame: Measured as events occur during the life of the trial.
measure: All-cause hospitalization rates
timeFrame: Measured as events occur during the life of the trial.
measure: CHF hospitalization rates
timeFrame: Measured as events occur during the life of the trial.
measure: Heart attack rates
timeFrame: Measured as events occur during the life of the trial.
measure: Worsening CHF event rates
timeFrame: Measured as events occur during the life of the trial.
measure: Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates
timeFrame: Measured as events occur during the life of the trial.
measure: Cost
timeFrame: Measured throughout the life of the trial.
measure: Quality of life
timeFrame: Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Heart Clinic Arkansas
state: Arkansas
city: Long Beach
country: United States
facility: Memorial Heart Institute
state: California
city: Los Angeles
country: United States
facility: Ahmanson-University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Diego
country: United States
facility: University of California at San Diego Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Fort Collins
country: United States
facility: Heart and Vascular Clinic of Northern Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Veterans Affairs Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Southwest Florida Heart Group
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Augusta
country: United States
facility: Cardiovascular Associates of Augusta
state: Georgia
city: Savannah
country: United States
facility: Heart and Lung Group of Savannah
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Saint John Hospital and Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute-Saint Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Cardiology, P.C.
state: Montana
city: Lincoln
country: United States
facility: Bryan Lincoln General Hospital
state: Nebraska
city: New Brunswick
country: United States
facility: University of Medicine & Dentistry of New Jersey
state: New Jersey
city: Westwood
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
city: Concord
country: United States
facility: Northeast Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Davis Heart and Lung Research Institute
state: Ohio
city: Toledo
country: United States
facility: Medical University of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Lynchburg
country: United States
facility: Lynchburg General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba Health Sciences Center
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Saint Michaels Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sainte Foy
country: Canada
facility: Laval Hospital
state: Quebec
city: Caen
country: France
facility: CHU de Caen
city: Clichy
country: France
facility: Hopital Beaujon Cardiologie
city: Creteil
country: France
facility: Hopital Henri Mondor-Service de C
city: Paris
country: France
facility: Hopital Broussais
city: Saint Denis
country: France
facility: Centre Cardiologie du Nord
city: Vandoeuvre Les Nancy
country: France
facility: Hopital Brabois
Study officials:
affiliation: Duke University
name: Christopher M. O'Connor
role: STUDY_CHAIR
affiliation: Jefferson Medical College of Thomas Jefferson University
name: David J. Whellan
role: STUDY_CHAIR
References:
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