HF-ACTION

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。心力衰竭和一项调查运动训练结果的对照试验(HF-ACTION)是一项多中心的国际随机试验，它解决了一个主要假设，即在标准护理的基础上，接受运动训练的左心室收缩功能障碍和纽约心脏协会II-IV级症状的患者在两年内的死亡率和住院率将比只接受常规护理的患者低20%。疗效将被定义为全因死亡率和全因住院的主要综合终点。这些临床终点将得到生理、资源利用和生活质量终点的支持。所有患者将在基线、3个月、12个月和24个月(完成24个月随访者)进行气体交换运动试验。该试验的目的是招募到2007年4月(注意每个NHLBI的招募期限延长，这是UAB IRB批准的)，每个患者至少随访12个月。功率计算：对照组的预期年度基线事件发生率为30%。预计第一年的辍学率为25%-35%，10%-15%，每年的交流率为5%。使用这些假设，3000名受试者的总样本量将被要求在阿尔法水平为0.05，幂为90%的情况下，主要结果减少20%。

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%.