CLINICAL TRIAL: HF ACTION

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Overview of the HF-ACTION Trial Heart Failure and A Control Trial Investigating Outcomes of Exercise Training (HF-ACTION) is a multicenter, international, randomized trial that addresses the primary hypothesis that patients with left ventricular (LV) systolic dysfunction and New York Heart Association (NYHA) class II-V symptoms, who are given exercise training in addition to standard care, will have a lower rate of death and hospitalization over two years than patients who receive usual care alone. Important secondary endpoints include exercise testing parameters, economics, quality of life, and depression. Over three years, regional centers in the United States and Canada and their satellite centers will recruit 3,000 consenting patients with congestive heart failure (CHF), LV ejection fraction (EF) 20% reduction in the primary endpoint of all-cause death and all-cause hospitalization with a 90% power from the projected annual usual care group event rate of 30%. If we allow for 30% non-adherence and drop-out from the intervention group during the first year and 12.5% annually thereafter, and for 5% cross-over to exercise per year for usual care patients (with crossover patients conservatively assumed to have their event rate reduced by 20%), the sample size of 3,000 patients will provide 90% power for detecting an overall 11% event-rate reduction. The results of the HF-ACTION trial will have a significant impact on the health and quality of life of millions of patients who now suffer from CHF.