Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF)
Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF)
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DOI：
10.1253/circj.cj-17-0323
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发表时间：
2018-01-01
影响因子：
3.3
通讯作者：
Matsuzaki, Masunori
中科院分区：
文献类型：
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作者：
Tsutsui, Hiroyuki;Ito, Hiroshi;Matsuzaki, Masunori
背景：在Emphasis-HF研究中，盐皮质激素受体拮抗剂依普利酮可改善射血功能降低(HFrEF)的心力衰竭患者的临床预后。然而，类似的有效性和安全性尚未在日本患者中得到证实。我们在一项多中心、随机、双盲的安慰剂对照结果研究(ClinicalTrials.gov标识：NCT01115855)中评估了依普利酮在HFrEF患者中的有效性和安全性。这项研究的目的是评估疗效，预先定义为主要终点与重点-HF的一致性，估计点为
Background: The mineralocorticoid receptor antagonist eplerenone improved clinical outcomes among patients with heart failure with reduced ejection faction (HFrEF) in the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure) study. However, similar efficacy and safety have not been established in Japanese patients. We evaluated the efficacy and safety of eplerenone in patients with HFrEF in a multicenter, randomized, double-blind placebo-controlled outcome study (ClinicalTrials.gov Identifier: NCT01115855). The aim of the study was to evaluate efficacy predefined as consistency of the primary endpoint with that of EMPHASIS-HF at a point estimate of