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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00047437
First received: October 3, 2002
Last updated: March 20, 2013
Last verified: March 2013

October 3, 2002
March 20, 2013
April 2003
July 2008   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00047437 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure
Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Failure, Congestive
Behavioral: Supervised Exercise Training Program
Exercise 30 minutes minimum three times per week.
  • Active Comparator: 2
    Intervention: Behavioral: Supervised Exercise Training Program
  • No Intervention: 1

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2331
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France
 
NCT00047437
Pro00017406, U01HL063747, U01 HL64250, U01 HL64257, U01 HL64264, U01 HL64265, U01 HL66461, U01 HL66482, U01 HL66491, U01 HL66494, U01 HL66497, U01 HL66501, U01 HL68973, U01 HL68980
Yes
Duke University
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Christopher M. O'Connor Duke University
Study Chair: David J. Whellan Jefferson Medical College of Thomas Jefferson University
Duke University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP