Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study
Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study
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DOI：
10.1016/s0140-6736(10)61198-1
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发表时间：
2010-09-11
期刊：
影响因子：
168.9
通讯作者：
Tavazzi, Luigi
中科院分区：
文献类型：
--
作者：
Swedberg, Karl;Komajda, Michel;Tavazzi, Luigi
背景：慢性心力衰竭与高死亡率和发病率相关。静息心率升高是不良后果的危险因素。我们的目的是评估选择性窦结抑制剂伊伐布雷定降低心率对心力衰竭结局的影响。方法：如果患者有症状性心力衰竭，左心室射血分数为35%或更低，心率为70次/分或更高的窦性心律，在过去一年内因心力衰竭住院，并且接受稳定的背景治疗，包括耐受的-受体阻滞剂，则有资格参加这项随机、双盲、安慰剂对照、平行组研究。患者通过计算机生成的分配计划随机分配到伊伐布雷定，每日两次，最大剂量为7.5 mg或匹配安慰剂。患者和调查人员对治疗分配不知情。主要终点是心血管死亡或因心力衰竭恶化而住院。分析的目的是治疗。该试验已注册，编号为ISRCTN70429960。结果6558例患者被随机分配到治疗组（伊伐布雷定3268例，安慰剂3290例）。数据可用于分析伊瓦布雷定组3241例患者和安慰剂组3264例患者。中位随访时间为22.9个月（IQR 18-28）。伊瓦布雷定组793例（24%）患者和安慰剂组937例（29%）患者出现主要终点事件（HR 0.82, 95% CI 0.75-0.90, p . 572）
Background Chronic heart failure is associated with high mortality and morbidity. Raised resting heart rate is a risk factor for adverse outcomes. We aimed to assess the effect of heart-rate reduction by the selective sinus-node inhibitor ivabradine on outcomes in heart failure.Methods Patients were eligible for participation in this randomised, double-blind, placebo-controlled, parallel-group study if they had symptomatic heart failure and a left-ventricular ejection fraction of 35% or lower, were in sinus rhythm with heart rate 70 beats per min or higher, had been admitted to hospital for heart failure within the previous year, and were on stable background treatment including a beta blocker if tolerated. Patients were randomly assigned by computer-generated allocation schedule to ivabradine titrated to a maximum of 7.5 mg twice daily or matching placebo. Patients and investigators were masked to treatment allocation. The primary endpoint was the composite of cardiovascular death or hospital admission for worsening heart failure. Analysis was by intention to treat. This trial is registered, number ISRCTN70429960.Findings 6558 patients were randomly assigned to treatment groups (3268 ivabradine, 3290 placebo). Data were available for analysis for 3241 patients in the ivabradine group and 3264 patients allocated placebo. Median follow-up was 22.9 (IQR 18-28) months. 793 (24%) patients in the ivabradine group and 937 (29%) of those taking placebo had a primary endpoint event (HR 0.82, 95% CI 0.75-0.90, p