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

Cardiovascular Diseases Clinical Trial

Official title:

Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047437
• Other study ID #: Pro00017406
• Secondary ID: U01HL063747U01HL
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2002
• Last updated: March 20, 2013
• Start date: April 2003
• Est. completion date: July 2008

Study information

• Verified date: March 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 2331
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Heart Failure, Congestive

Intervention

Behavioral:
• Supervised Exercise Training Program
Exercise 30 minutes minimum three times per week.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	London Health Sciences Center	London	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Laval Hospital	Sainte Foy	Quebec
Canada	Saint Michaels Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	University of Manitoba Health Sciences Center	Winnipeg	Manitoba
France	CHU de Caen	Caen
France	Hopital Beaujon Cardiologie	Clichy
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
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University Hospital	Atlanta	Georgia
United States	Morehouse School of Medicine	Atlanta	Georgia
United States	Cardiovascular Associates of Augusta	Augusta	Georgia
United States	Johns Hopkins University Medical Center	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Northwestern University Medical Center	Chicago	Illinois
United States	University of Chicago Hospitals	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Davis Heart and Lung Research Institute	Columbus	Ohio
United States	Northeast Medical Center	Concord	North Carolina
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Saint John Hospital and Medical Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Heart and Vascular Clinic of Northern Colorado	Fort Collins	Colorado
United States	Southwest Florida Heart Group	Fort Myers	Florida
United States	University of Florida	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	The Care Group, LLC	Indianapolis	Indiana
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	Mayo Clinic	Jacksonville	Florida
United States	Glacier View Cardiology, P.C.	Kalispell	Montana
United States	Mid America Heart Institute-Saint Luke's Hospital	Kansas City	Missouri
United States	Bryan Lincoln General Hospital	Lincoln	Nebraska
United States	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 Louisville	Louisville	Kentucky
United States	Lynchburg General Hospital	Lynchburg	Virginia
United States	University of Wisconsin Madison	Madison	Wisconsin
United States	Aurora Health Care	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Saint Thomas Hospital	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Medicine & Dentistry of New Jersey	New Brunswick	New Jersey
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Sciences University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Saint Francis Hospital	Roslyn	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of California, Davis Medical Center	Sacramento	California
United States	LDS Hospital	Salt Lake City	Utah
United States	University of California at San Diego Medical Center	San Diego	California
United States	Heart and Lung Group of Savannah	Savannah	Georgia
United States	University of Washington Medical Center	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Medical University of Ohio	Toledo	Ohio
United States	Veterans Affairs Medical Center	Washington	District of Columbia
United States	Hackensack University Medical Center	Westwood	New Jersey
United States	Central DuPage Hospital	Winfield	Illinois
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada,  France, 

References & Publications (1)

Whellan DJ, O'Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Houston-Miller N, Fleg JL, Schulman KA, Piña IL; HF-ACTION Trial Investigators. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J. 2007 Feb;153(2):201-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3)		Measured as events occur during the lifespan of the trial.	Yes
Secondary	Changes in peak VO2		Measured at 3 months, 12 months, and 24 months.	No
Secondary	Changes in VE/VCO2 slope		Measured at 3 months, 12 months, and 24 months.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Composite of cardiovascular mortality and cardiovascular hospitalization rates		Measured as events occur during the life of the trial.	Yes
Secondary	Composite of cardiovascular mortality and CHF hospitalization rates		Measured as events occur during the life of the trial.	Yes
Secondary	All-cause mortality rates		Measured as events occur during the life of the trial.	Yes
Secondary	Cardiovascular mortality rates		Measured as events occur during the life of the trial.	Yes
Secondary	All-cause hospitalization rates		Measured as events occur during the life of the trial.	Yes
Secondary	CHF hospitalization rates		Measured as events occur during the life of the trial.	Yes
Secondary	Heart attack rates		Measured as events occur during the life of the trial.	Yes
Secondary	Worsening CHF event rates		Measured as events occur during the life of the trial.	Yes
Secondary	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.	Yes
Secondary	Cost		Measured throughout the life of the trial.	No
Secondary	Quality of life		Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study	No