Effect of Spironolactone on Diastolic Function and Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction The Aldo-DHF Randomized Controlled Trial
Effect of Spironolactone on Diastolic Function and Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction The Aldo-DHF Randomized Controlled Trial
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DOI：
10.1001/jama.2013.905
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发表时间：
2013-02-27
影响因子：
120.7
通讯作者：
Pieske, Burkert
中科院分区：
文献类型：
--
作者：
Edelmann, Frank;Wachter, Rolf;Pieske, Burkert
重要性舒张性心力衰竭（即射血分数保留的心力衰竭）是一种常见的疾病，没有既定的治疗，醛固酮刺激可能有助于其progress.Objective评估长期醛固酮受体阻滞剂在射血分数保留的心力衰竭的疗效和安全性。主要目的是确定螺内酯在改善射血分数保留的心力衰竭患者的舒张功能和最大运动能力方面是否上级安慰剂。2007年3月至2012年4月在德国和奥地利的10家研究中心进行的安慰剂对照试验，纳入了422例非卧床患者（平均年龄，67 [SD，8]岁; 52%女性）患有慢性纽约心脏协会II或III级心力衰竭，左心室射血分数保持在50%或更高，干预患者被随机分配接受25 mg螺内酯每日一次（n=213）或匹配的安慰剂（n=209）主要观察指标：心脏超声心动图舒张功能（E/e '）和心肺运动试验最大运动能力（峰值（V）/dotO（2））的变化，两项指标均在12个月时测量。结果舒张功能（E/e'）从12. 7安体舒通组从12.8（SD，3.6）增加到12.1（SD，3.7），安慰剂组从12.8（SD，4.4）增加到13.6（SD，4.3）（校正平均差异，-1.5; 95%CI，-2.0至-0.9; P
Importance Diastolic heart failure (ie, heart failure with preserved ejection fraction) is a common condition without established therapy, and aldosterone stimulation may contribute to its progression.Objective To assess the efficacy and safety of long-term aldosterone receptor blockade in heart failure with preserved ejection fraction. The primary objective was to determine whether spironolactone is superior to placebo in improving diastolic function and maximal exercise capacity in patients with heart failure with preserved ejection fraction.Design and Setting The Aldo-DHF trial, a multicenter, prospective, randomized, double-blind, placebo-controlled trial conducted between March 2007 and April 2012 at 10 sites in Germany and Austria that included 422 ambulatory patients (mean age, 67 [SD, 8] years; 52% female) with chronic New York Heart Association class II or III heart failure, preserved left ventricular ejection fraction of 50% or greater, and evidence of diastolic dysfunction.Intervention Patients were randomly assigned to receive 25 mg of spironolactone once daily (n=213) or matching placebo (n=209) with 12 months of follow-up.Main Outcome Measures The equally ranked co-primary end points were changes in diastolic function (E/e') on echocardiography and maximal exercise capacity (peak (V)over dotO(2)) on cardiopulmonary exercise testing, both measured at 12 months.Results Diastolic function (E/e') decreased from 12.7 (SD, 3.6) to 12.1 (SD, 3.7) with spironolactone and increased from 12.8 (SD, 4.4) to 13.6 (SD, 4.3) with placebo (adjusted mean difference, -1.5; 95% CI, -2.0 to -0.9; P