HF ACTION

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。HF-ACTION试验概述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、国际、随机试验，旨在解决左心室（LV）收缩功能障碍和纽约心脏协会（NYHA） II-V级症状的患者的主要假设，这些患者在标准治疗的基础上给予运动训练，在两年内的死亡率和住院率低于单独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。在三年多的时间里，美国和加拿大的区域中心及其卫星中心将招募3000名知情同意的充血性心力衰竭（CHF）、左室射血分数（EF）患者，全因死亡和全因住院的主要终点降低20%，预计每年常规护理组事件发生率为30%，发生率为90%。如果我们允许第一年有30%的不遵守和退出干预组，此后每年有12.5%的不遵守和退出干预组，并且允许5%的常规护理患者每年进行交叉锻炼（保守地假设交叉患者的事件发生率降低20%），3,000例患者的样本容量将提供90%的能力来检测总体事件发生率降低11%。HF-ACTION试验的结果将对数百万慢性心力衰竭患者的健康和生活质量产生重大影响。#该协议仍处于招募和数据收集阶段。

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 excercise 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. #This protocol is still in the recruitment and data colletion phase.