Recovery Post Exercise A Substudy of the HF-ACTION Trial

描述(由申请人提供)： 本申请是NHLBI赞助的HF-ACTION试验的拟议辅助研究。以下是父母试验的简要总结。完整的协议将在本赠款申请的附录A中找到。HF-ACTION试验：摘要描述HF-ACTION的主要目的是确定除了标准治疗与单独使用标准治疗策略外，对NYHA II-IV级心力衰竭(HF)患者进行运动训练的长期安全性和有效性。第二个目的是确定运动引起的并发症的发生率和意义。作为这一目标的一部分，这项研究将确定将从运动中受益或风险增加的患者的具体特征。HF-ACTION的主要终点是所有原因死亡率和所有原因住院的综合终点。运动训练将包括总共36个监督训练课程，随后是家庭训练计划和间歇监督训练课程。训练将以基线心肺测试(CPX)确定的心率储备的60%-70%进行。功效将被定义为主要的组合终点。这些临床终点将得到经济资源利用和健康状况评估(生活质量)的支持。HF-ACTION试验致力于招募少数族裔患者，包括妇女、非裔美国人、西班牙裔和老年人。有关完整的HF-ACTION协议和摘要，请参见附录A。(摘要结束)

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)