A complete description of the design of HF-ACTION has been published previously.15 (link) Briefly, HF-ACTION was a multicenter, randomized controlled trial of exercise training vs usual care in patients with left ventricular ejection fraction ≤ 35% and New York Heart Association (NYHA) class II to IV symptoms despite optimal heart failure therapy for at least 6 weeks. Patients were randomized from April 2003 through February 2007 within the United States, Canada, and France. 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. The protocol was reviewed and approved by the appropriate institutional review board or ethics committee for each participating center and by the coordinating center institutional review board. All patients provided written voluntary informed consent.
All patients were to undergo 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. Eligible patients were randomized 1:1 using a permuted block randomization scheme, stratified by clinical center and heart failure etiology (ischemic vs nonischemic). At the baseline clinic visit prior to randomization, demographics, socioeconomic status, past medical history, current medications, physical exam, and the most recent laboratory tests were obtained. Participants reported race and ethnicity at the time of study enrollment using categories defined by the National Institutes of Health. In an analysis to examine the effect of exercise training by subgroup, we used the reported race categories “black or African American” and “white” and combined all others as “other.” All cardiopulmonary exercise tests were sent to the HF-ACTION cardiopulmonary exercise core lab for review.
All patients were to undergo 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. Eligible patients were randomized 1:1 using a permuted block randomization scheme, stratified by clinical center and heart failure etiology (ischemic vs nonischemic). At the baseline clinic visit prior to randomization, demographics, socioeconomic status, past medical history, current medications, physical exam, and the most recent laboratory tests were obtained. Participants reported race and ethnicity at the time of study enrollment using categories defined by the National Institutes of Health. In an analysis to examine the effect of exercise training by subgroup, we used the reported race categories “black or African American” and “white” and combined all others as “other.” All cardiopulmonary exercise tests were sent to the HF-ACTION cardiopulmonary exercise core lab for review.
