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. Heart Failure and A Controlled 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 Classes II-IV symptoms who are given exercise training in addition to standard care will have a > 20% lower rate of death and hospitalizations over two years than patients who receive usual care alone. Efficacy will be defined as the primary combined endpoint of all-cause mortality and all-cause hospitalizations. These clinical endpoints will be supported by physiological, resource utilization, and quality-of-life endpoints. All patients will perform gas exchange exercise tests at baseline, 3, 12, and 24 months (for those who complete 24 months of follow-up). The trial is designed to recruit through April 2007 (note extension of recruitment period per NHLBI which is UAB IRB approved) with a minimum follow-up of 12 months for each patient. Power calculation: The expected annual baseline event rate is 30% for the control group. The expected drop-out rate is 25-35% the first year and 10-15%, with a cross-over rate of 5% per year. Using these assumptions, a total sample size of 3000 subjects will be required to see a 20% reduction in the primary outcome with an alpha level of 0.05 and a power of 90%.