Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, #180 Fenglin Road, Xuhui District, Shanghai, 200032, China.
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Am J Cardiovasc Drugs. 2022 May;22(3):345-354. doi: 10.1007/s40256-021-00500-x. Epub 2021 Dec 8.
Ivabradine improves cardiac function and clinical outcomes in chronic heart failure (HF) by reducing heart rate (HR), but there is a lack of real-world data on its effectiveness and safety in Chinese patients.
We designed a prospective, multicenter, observational study of Chinese adults with HF and left ventricular systolic dysfunction, resting HR ≥ 75 beats per minute (bpm), and an indication for ivabradine treatment. An interim analysis was performed using a cut-off date of 31 October 2019. The primary outcome was change in HR at 6 months after the initiation of ivabradine. Secondary endpoints included change in New York Heart Association (NYHA) functional class; quality of life (QoL), measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ); and adverse events (AEs).
Overall, 655 subjects were included in the interim analysis. Mean reduction in HR from baseline was 13.2 (95% confidence interval [CI] 11.2-15.2) bpm at Month 1, and 14.5 (95% CI 11.8-17.2) bpm at Month 6 (p < 0.001 for both changes). NYHA functional class and KCCQ scores improved significantly over time (p < 0.001 for all comparisons with baseline), indicating amelioration of symptoms and better QoL, respectively. Forty-four subjects (6.7%) reported a total of 60 ivabradine-related AEs, most frequently phosphenes and bradycardia (both n = 6, 0.9%).
Treatment with ivabradine for 6 months effectively reduced HR and improved functional class and QoL in Chinese patients with chronic HF. Treatment was well tolerated.
ISRCTN11703380; registered on 8 November 2016.
伊伐布雷定通过降低心率（HR）改善慢性心力衰竭（HF）患者的心脏功能和临床结局，但在中国人中，关于其有效性和安全性的真实世界数据仍较为缺乏。
我们设计了一项前瞻性、多中心、观察性研究，纳入中国患有 HF 和左心室收缩功能障碍、静息 HR≥75 次/分（bpm）且有伊伐布雷定治疗指征的成年人。采用 2019 年 10 月 31 日的截止日期进行中期分析。主要结局为伊伐布雷定起始后 6 个月时的 HR 变化。次要终点包括纽约心脏协会（NYHA）功能分级的变化；生活质量（QoL），采用堪萨斯城心肌病问卷（KCCQ）进行测量；以及不良事件（AE）。
共有 655 例受试者纳入中期分析。与基线相比，HR 从第 1 个月开始下降 13.2（95%置信区间[CI] 11.2-15.2）bpm，第 6 个月下降 14.5（95% CI 11.8-17.2）bpm（两者变化均 p<0.001）。NYHA 功能分级和 KCCQ 评分随时间显著改善（与基线相比所有比较均 p<0.001），分别表明症状改善和 QoL 提高。44 例（6.7%）受试者共报告了 60 例伊伐布雷定相关的 AE，最常见的是幻视和心动过缓（均 n=6，0.9%）。
伊伐布雷定治疗 6 个月可有效降低中国慢性 HF 患者的 HR，并改善其功能分级和 QoL。治疗具有良好的耐受性。
ISRCTN83620774；于 2016 年 11 月 8 日注册。
