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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Diseases, Cardiovascular Diseases, Heart Failure, Congestive

Intervention / Treatment
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* Behavioral: Supervised Exercise Training Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br> | Behavioral: Supervised Exercise Training Program<br>* Exercise 30 minutes minimum three times per week.<br>|
| No Intervention: 1<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |