Su Yang, Ma Teng, Wang Zeyu, Dong Bin, Tai Chenhui, Wang Hao, Zhang Fenglei, Yan Chunxi, Chen Wei, Xu Yawei, Ye Lei, Tye Gee Jun, Ong Sang-Bing, Zhang Jian, Xu Dachun
Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, 200072, China.
Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
ESC Heart Fail. 2020 Dec;7(6):4465-4471. doi: 10.1002/ehf2.12997. Epub 2020 Sep 18.
Elevated heart rate (HR) in heart failure (HF) is associated with worse outcomes, particularly in acute HF (AHF). HR reduction with ivabradine reduces cardiovascular events in HF patients with reduced ejection fraction. The present trial aimed to test the hypothesis that the early HR reduction using ivabradine improves clinical outcomes in patients with AHF.
SHIFT-AHF is a prospective, multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of ivabradine when adding to standard therapy in AHF patients (SHIFT-AHF). The trial will include 674 AHF patients with left ventricular ejection fraction < 45% and New York Heart Association functional classes III-IV. Participants were enrolled from March 2020 and will be followed up until December 2022. Patients are randomized to treatment with ivabradine or placebo (randomization 1:1). After allocation, the dose of ivabradine is titrated according to HR. Six months' follow-up and three control visits (7, 90, and 180 days after enrolment) are required for every participant. Assessment involves clinical examination, laboratory tests, echocardiography, electrocardiography, heart rhythm, cardiac function, and quality of life. The primary endpoint is a composite of all-cause mortality or re-admission due to worsening HF. Secondary endpoints include the assessments of cardiac remodelling, cardiac functional capacity, and quality of life.
The SHIFT-AHF trial will shed further light on the role of early HR reduction using ivabradine in patients with AHF.
心力衰竭（HF）患者心率（HR）升高与预后较差相关，尤其是在急性心力衰竭（AHF）中。伊伐布雷定降低心率可减少射血分数降低的HF患者的心血管事件。本试验旨在检验以下假设：使用伊伐布雷定早期降低心率可改善AHF患者的临床结局。
SHIFT-AHF是一项前瞻性、多中心、双盲、随机、安慰剂对照试验，旨在评估伊伐布雷定在AHF患者（SHIFT-AHF）中添加到标准治疗时的疗效和安全性。该试验将纳入674例左心室射血分数<45%且纽约心脏协会心功能分级为III-IV级的AHF患者。参与者于2020年3月入组，并将随访至2022年12月。患者被随机分配接受伊伐布雷定或安慰剂治疗（随机比例为1:1）。分配后，根据心率调整伊伐布雷定的剂量。每位参与者需要进行6个月的随访和3次对照访视（入组后7天、90天和180天）。评估包括临床检查、实验室检查、超声心动图、心电图、心律、心功能和生活质量。主要终点是全因死亡率或因HF恶化再次入院的复合终点。次要终点包括心脏重塑、心功能能力和生活质量的评估。
SHIFT-AHF试验将进一步阐明使用伊伐布雷定早期降低心率在AHF患者中的作用。
