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. The HF-ACTION study is a multicenter, prospective, randomized clinical trial of Usual care plus Exercise Training versus Usual Care for the prevention of all-cause mortality or hospitalization in 3,000 patients with NYHA class II, III, or IV HF and EF 35%. The UNMH Center will endeavor to enter 30 patisnts. The primary objective is to test the hypothesis that patients with LV systolic dysfunction and NYHA class II-IV symptoms who are given exercise training in addition to usual care will have a 20% lower rate of death and hospitalization over two years than patients who receive usual care alone. Secondary hypotheses are, that the risks associated with exercise training are outweighed by the benefits, that the intervention will significantly improve exercise tolerance, that the intervention will significantly improve the quality of life, and that the intervention will be economically attractive (cost saving or a reasonable value for money). The study population has been chosen to achieve a wide applicability of the results. Patients will be selected from the registry of patients in the Heart Failure Clinic. The patients will have an echocardiogram, will do a 6-minute walk test, and a CPX test. The latter will be repeated several times throughout the study. Patients will be randomized to Usual Care only or Usual Care plus exercise Training. Initially, the latter group will have 36 supervised training sessions in the Cardiac Rehabilitation Unit. After this they will be supplied with a treadmill or exercise bicycle which will be supplied free of charge and may be kept after the trial closes. There will be periodic supervised training sessions. Blood will be drawn once and sent to the Duke University Research Institute where it will be kept and used for studies of biomarkers yet to be decided upon.