Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
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April 2003 – July 2008
June 8, 2015
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions Yes
Data Restrictions Based On Area Of Research No
Specific Consent Restrictions
Consent for use of data by commercial investigators is tiered.
The HF-ACTION study examined whether exercise training reduces a composite endpoint of all-cause mortality or all-cause hospitalization for patients with left ventricular systolic dysfunction and heart failure symptoms.
Heart failure (HF) is a major and growing cardiovascular syndrome that is the end result of many cardiovascular disorders. Although evidence-based drug and device therapies decrease mortality, hospitalizations, and HF symptoms and improve quality of life, many patients treated with these regimens often remain burdened by dyspnea and fatigue, diminished exercise tolerance, reduced quality of life, recurrent hospitalizations, and early mortality.
Whereas rest was traditionally recommended for HF patients, there has been evidence that physical deconditioning may play a key role in the progression of symptoms and poor outcomes. Previous studies have shown positive effects of exercise training on exercise capacity, quality of life, and biomarkers and suggest that exercise training might improve survival and decrease HF hospitalizations. Nonetheless, there remains a safety concern regarding exercise training in HF and a large scale, multicenter, controlled clinical trial was needed to provide definitive clinical outcome data.
Eligible patients must have had left ventricular ejection fraction ≤ 35% and New York Heart Association class II to IV symptoms despite optimal HF therapy for at least 6 weeks. Exclusion criteria included major comorbidities or limitations that could interfere with exercise training, recent (within 6 weeks) or planned (within 6 months) major cardiovascular events or procedures, performance of regular exercise training, or use of devices that limited the ability to achieve target heart rates.
A total of 2331 subjects were randomized. 2130 consented to share data with non-commercial entities, and 1753 consented to share for commercial purposes.
All participants underwent baseline cardiopulmonary exercise testing. Test results were reviewed by investigators to identify significant arrhythmias or ischemia that would prevent safe exercise training, to determine appropriate levels of exercise training, and to establish training heart rate ranges. Demographics, socioeconomic status, past medical history, current medications, physical exam, and the most recent laboratory tests were obtained prior to randomization. All participants received detailed self-management educational materials which included information on medications, fluid management, symptom exacerbation, sodium intake, and physical activity.
Subjects randomized to the exercise training arm first participated in a structured, group-based, supervised exercise program, with a goal of 3 sessions per week for a total of 36 sessions in 3 months. The primary exercises were walking, treadmill, or stationary cycling. Exercise was initiated at 15 to 30 minutes per session at a heart rate corresponding to 60% of heart rate reserve, and was increased after 6 sessions to 30 to 35 minutes duration and 70% of heart rate reserve. Subjects began home-based exercise after completing 18 supervised sessions and were to fully transition to home exercise after 36 supervised sessions. The target training regimen for home exercise was 5 times per week for 40 minutes at a heart rate of 60% to 70% of heart rate reserve.
Subjects randomized to the usual care group were not provided with a formal exercise prescription. To provide comparable levels of attention from study personnel, all subjects were called every 2 weeks for the first 9 months, monthly until 24 months of follow-up, and quarterly thereafter. Subjects returned for clinic visits every 3 months for the first 2 years of participation and yearly thereafter for up to 4 years. Follow-up assessments included cardiopulmonary exercise testing, a 6-minute walk test, and a physical activity questionnaire.
The primary end point was a composite of all-cause mortality or all-cause hospitalization. Secondary end points included all-cause mortality, the composite of cardiovascular mortality or cardiovascular hospitalization, and the composite of cardiovascular mortality or HF hospitalization.
After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modestly significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization.
JAMA. 2009 Apr 8;301(14):1439-50.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 792.4 KB)
- Exercise Manual (PDF - 177.5 KB)
- Forms (PDF - 6.5 MB)
- MOO (PDF - 5.4 MB)
- Protocol (PDF - 1.3 MB)
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