CLINICAL TRIAL: HF ACTION

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 高频动作试验综述 调查运动训练结果的心力衰竭和对照试验(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，即除了标准护理外，接受运动训练的左心室(LV)收缩功能障碍和纽约心脏协会(NYHA)II-V级症状的患者在两年内的死亡率和住院率将低于仅接受常规护理的患者。重要的次要终点包括运动测试参数、经济、生活质量和抑郁。 在三年的时间里，美国和加拿大的地区中心及其卫星中心将招募3000名心力衰竭(CHF)、左心室射血分数(EF)降低20%、全因死亡的主要终点和全因住院的患者，这比预计的年度常规护理团体事件发生率30%高出90%。如果我们允许干预组在第一年有30%的不坚持和退出，此后每年12.5%，对于普通护理患者(保守地假设跨界患者的事件发生率降低20%)，每年5%的交叉锻炼，3000名患者的样本量将提供90%的力量来检测总体11%的事件发生率降低。HF-ACTION试验的结果将对数百万现在患有CHF的患者的健康和生活质量产生重大影响。

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. Overview of the HF-ACTION Trial Heart Failure and A Control 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 (NYHA) class II-V symptoms, who are given exercise training in addition to standard care, will have a lower rate of death and hospitalization over two years than patients who receive usual care alone. Important secondary endpoints include exercise testing parameters, economics, quality of life, and depression. Over three years, regional centers in the United States and Canada and their satellite centers will recruit 3,000 consenting patients with congestive heart failure (CHF), LV ejection fraction (EF) 20% reduction in the primary endpoint of all-cause death and all-cause hospitalization with a 90% power from the projected annual usual care group event rate of 30%. If we allow for 30% non-adherence and drop-out from the intervention group during the first year and 12.5% annually thereafter, and for 5% cross-over to exercise per year for usual care patients (with crossover patients conservatively assumed to have their event rate reduced by 20%), the sample size of 3,000 patients will provide 90% power for detecting an overall 11% event-rate reduction. 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 CHF.