DESCRIPTION (provided by applicant): This application is a proposed ancillary study of the NHLBI Sponsored HF- ACTION Trial. A brief summary of the parent trial follows. The full protocol will be found in Appendix A of this grant application. HF-ACTION TRIAL: Summary Description The primary aim of HF-ACTION is to determine the long-term safety and efficacy of exercise training for NYHA Class II-IV heart failure (HF) patients in addition to standard care vs. a strategy of standard care alone. The secondary aim is to determine the incidence and significance of exercise induced complications. As part of this objective, the study will determine the specific characteristics of patients who will derive benefit or those with increased risk from exercise. The primary endpoint of HF-ACTION is a combined endpoint of all cause mortality and all cause hospitalization. The exercise training will include a total of 36 supervised training sessions followed by a home exercise program and interval supervised sessions. Training will be at 60-70% of the heart rate reserve as determined by baseline cardiopulmonary testing (CPX). Efficacy will be defined as the primary combined endpoint. These clinical endpoints will be supported by economic resource utilization, and health status assessment (quality of life). The HF-ACTION trial is committed to the enrollment of minority patients including women, African Americans, Hispanics and the elderly. See Appendix A for the full HF-ACTION protocol and a synopsis. (End of Abstract)
|Effective start/end date||9/30/07 → 6/30/10|
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