This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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. Important secondary endpoints include exercise testing parameters, economics, quality of life, and depression. Other objectives of this trial include determining the incidence and significance of exercise-related complications and determining patient specific correlates of benefit and risk from exercise.Patients in the intervention exercise training arm undergo 36 supervised training sessions followed by home exercise and interval supervised sessions. Training intensity is set at 60% to 70% of peak V02. 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). All randomized patients receive follow-up in clinic and telephone calls at pre-specified times. Power calculation at trial inception: 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%. Enrollment for the trial ended on February 28, 2007 (i.e. the recruitment period was lengthened by 11 months). Each patient will have a minimum follow-up of 12 months. Anticipated enrollment at UAB was 90 patients as stated above, however, only 60 patients were enrolled. Trial wide, 2331 patients have been enrolled. Despite the smaller sample size, power is believed to be adequate to address the endpoints as outlined because of longer follow-up. Detailed revised power calculations done by the Coordinating Center statistician are not available to individual participating sites. This center is one of 67 regional centers throughout the US (52 sites), Canada (9 sites), and France (6 sites) to participate in the HF-ACTION Trial, with the Duke Clinical Research Institute as the coordinating center. 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 heart failure.
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