HEART FAILURE PATIENT EXERCISE TRAINING

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。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，其主要假设是左心室（LV）收缩功能障碍和纽约心脏协会（NYHA） II-IV级症状的患者在标准治疗的基础上进行运动训练，两年内的死亡率和住院率比单独接受常规治疗的患者低20%。重要的次要终点包括运动测试参数、经济、生活质量和抑郁。在三年内，美国和加拿大的区域中心及其卫星中心将招募3000名心衰（HF），左室射血分数（EF） 35%， NYHA II-IV级的同意患者。一旦确定和筛选，这些患者将以1:1的方式随机接受常规护理或常规护理加运动训练。干预组的患者将接受36次有监督的运动训练，然后开始家庭运动训练方案，并辅以偶尔的有监督的复习训练。所有患者将在基线、3个月、12个月和24个月随访时进行气体交换运动试验。所有随机抽取的患者将在预先指定的时间接受随访门诊和电话。将保留拒绝参加试验的符合条件的患者的临床信息登记。HF- action试验的结果将对数百万心衰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. 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 (NYHA) class II-IV symptoms who are given exercise training in addition to standard care will have a 20% 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 heart failure (HF), LV ejection fraction (EF) 35%, and NYHA class II-IV. Once identified and screened, these patients will be randomized in a 1:1 fashion to receive usual care or usual care plus exercise training. Patients in the intervention arm will undergo 36 supervised exercise training sessions before initiating a home exercise training regimen that will be supplemented with occasional supervised review training sessions. All patients will perform gas exchange exercise tests at baseline, 3 months, 12 months, and 24 months of follow-up. All randomized patients will receive follow-up clinic and telephone calls at pre-specified times. Registries of clinical information will be maintained on eligible patients who decline trial entry. 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 HF.