Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial.
Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial.
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DOI：
10.1001/jama.2009.454
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发表时间：
2009-04-08
影响因子：
120.7
通讯作者：
Pina, Ileana L.
中科院分区：
文献类型：
--
作者：
O'Connor, Christopher M.;Whellan, David J.;Lee, Kerry L.;Keteyian, Steven J.;Cooper, Lawton S.;Ellis, Stephen J.;Leifer, Eric S.;Kraus, William E.;Kitzman, Dalane W.;Blumenthal, James A.;Rendall, David S.;Miller, Nancy Houston;Fleg, Jerome L.;Schulman, Kevin A.;McKelvie, Robert S.;Zannad, Faiez;Pina, Ileana L.
指南建议，对于医学上稳定的心力衰竭门诊患者，应考虑进行运动训练。以前的研究没有足够的统计能力来衡量运动训练对临床结果的影响。目的：探讨运动训练对心力衰竭患者的疗效和安全性。2331例医学上稳定的心力衰竭和射血分数降低的门诊患者的多中心随机对照试验。心力衰竭：一项调查运动训练结果的对照试验（HF-ACTION）的参与者是从2003年4月到2007年2月在美国、加拿大和法国的82个中心随机抽取的；中位随访时间为30个月。常规护理加有氧运动训练，包括36次有监督的训练，然后是家庭训练，或者单独进行常规护理。全因死亡率或住院的复合主要终点和预先指定的全因死亡率、心血管死亡率或心血管住院、心血管死亡率或心力衰竭住院的复合次要终点。中位年龄为59岁，28%为女性，37%有纽约心脏协会III级或IV级症状。51%的病因为缺血性。左室射血分数中位数为25%。运动坚持度从随访第4到6个月的每周95分钟的中位数下降到随访第10到12个月的每周74分钟。运动组共有759例（65%）患者死亡或住院，而常规护理组有796例（68%）患者死亡或住院（风险比[HR]为0.93；95%可信区间[CI]为0.84-1.02;P = 0.13）。有无足轻重的死亡率降低运动训练小组(189 vs 198运动组(16%)(17%)在常规治疗组;人力资源,0.96;95%可信区间,0.79 - -1.17;P = 2),心血管死亡率或心血管住院(632 vs 677运动组(55%)(58%)在常规治疗组;人力资源,0.92;95%可信区间,0.83 - -1.03;P = .14点),和心血管死亡率或心力衰竭住院(344 vs 393运动组(30%)(34%)在常规治疗组;人力资源,0.87;95% ci, 0.75-1.00；P = .06)。在预先指定的补充分析中，调整了高度预后基线特征，全因死亡率或住院的hr为0.89 (95% CI, 0.81-0.99; P = 0.03)，心血管死亡率或心血管住院的hr为0.91 (95% CI, 0.82-1.01; P = 0.09)，心血管死亡率或心力衰竭住院的hr为0.85 （95% CI, 0.74-0.99; P = 0.03）。其他不良事件在两组之间相似。在方案指定的主要分析中，运动训练导致全因死亡率或住院的主要终点和关键的次要临床终点的无显著降低。在对主要终点的高度预后预测因素进行调整后，运动训练与全因死亡率或住院率、心血管死亡率或心力衰竭住院率的适度显著降低相关。clinicaltrials.gov标识符：NCT00047437
Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes. To test the efficacy and safety of exercise training among patients with heart failure. Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months. Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone. Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization. The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Etiology was ischemic in 51%. Median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 (65%) patients in the exercise group died or were hospitalized, compared with 796 (68%) in the usual care group (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.84–1.02; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 [16%] in the exercise group vs 198 [17%] in the usual care group; HR, 0.96; 95% CI, 0.79–1.17; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise group vs 677 [58%] in the usual care group; HR, 0.92; 95% CI, 0.83–1.03; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise group vs 393 [34%] in the usual care group; HR, 0.87; 95% CI, 0.75–1.00; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81–0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82–1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74–0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups. In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization. clinicaltrials.gov Identifier: NCT00047437
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