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。 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%。重要的次要终点包括运动测试参数、经济、生活质量和抑郁。这项试验的其他目标包括确定运动相关并发症的发生率和重要性，以及确定患者特定的运动益处和风险的相关性。 在干预运动训练组中，患者接受36次监督训练，然后是家庭训练和间歇监督训练。训练强度设定为V02峰值的60%至70%。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。所有随机抽样的患者都在预先指定的时间接受诊所的随访和电话采访。 试验开始时的功率计算：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%。 试验的招生截止日期为2007年2月28日(即招募期延长了11个月)。每个患者将有至少12个月的随访。如上所述，UAB的预期入选患者为90名，然而，只有60名患者入选。在整个试验范围内，已有2331名患者入选。尽管样本量较小，但由于随访时间较长，相信电力足以解决所述的终点问题。协调中心统计员所做的详细修订功率计算不适用于个别参与地点。 该中心是美国(52个地点)、加拿大(9个地点)和法国(6个地点)参与HF-ACTION试验的67个地区中心之一，杜克临床研究所是协调中心。HF-ACTION试验的结果将对数百万现在患有心力衰竭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. 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. Important secondary endpoints include exercise testing parameters, economics, quality of life, and depression. Other objectives of this trial include determining the incidence and significance of exercise-related complications and determining patient specific correlates of benefit and risk from exercise. Patients in the intervention exercise training arm undergo 36 supervised training sessions followed by home exercise and interval supervised sessions. Training intensity is set at 60% to 70% of peak V02. 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). All randomized patients receive follow-up in clinic and telephone calls at pre-specified times. Power calculation at trial inception: 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%. Enrollment for the trial ended on February 28, 2007 (i.e. the recruitment period was lengthened by 11 months). Each patient will have a minimum follow-up of 12 months. Anticipated enrollment at UAB was 90 patients as stated above, however, only 60 patients were enrolled. Trial wide, 2331 patients have been enrolled. Despite the smaller sample size, power is believed to be adequate to address the endpoints as outlined because of longer follow-up. Detailed revised power calculations done by the Coordinating Center statistician are not available to individual participating sites. This center is one of 67 regional centers throughout the US (52 sites), Canada (9 sites), and France (6 sites) to participate in the HF-ACTION Trial, with the Duke Clinical Research Institute as the coordinating center. 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 heart failure.