机构：[1]Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China[2]Hunan Provincial People’s Hospital,Changsha, China[3]Peking Union Medical College Hospital, Beijing, China[4]Beijing Hospital, Beijing, China[5]Fuwai Hospital, CAMS PUMC, Beijing, China[6]The First AffiliatedHospital of Xinjiang Medical University, Urumqi, China[7]Shanxi Cardiovascular Hospital, Taiyuan, China[8]West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[9]TheSecond Hospital of Hebei Medical University, Shijiazhuang, China[10]Peking University First Hospital, Beijing, China[11]Zhuji People’s Hospital, Shaoxing, China[12]Jinan CentralHospital Affiliated to Shandong University, Jinan, China[13]Beijing Anzhen Hospital, Capital Medical University, Beijing, China首都医科大学附属安贞医院[14]Huizhou Municipal Central Hospital, Huizhou,China[15]Affiliated Hospital of Zunyi Medical College, Zunyi, China[16]Jiangsu Province Hospital, Nanjing, China江苏省人民医院[17]Qilu Hospital of Shandong University (Qingdao), Qingdao,China[18]Beijing Tsinghua Changgung Hospital, Beijing, China[19]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[20]FirstPeople’s Hospital of Yunnan Province, Kunming, China[21]Tianjin Medical University General Hospital, Tianjin, China[22]The First Affiliated Hospital of Sun Yat-sen University,Guangzhou, China中山大学附属第一医院[23]Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Zhejiang, China[24]Servier (Tianjin) Pharmaceutical Co., Ltd, Beijing, China
Aims A therapeutic strategy for chronic heart failure (HF) is to lower resting heart rate (HR). Ivabradine is a well-known HR-lowering agent, but limited prospective data exist regarding its use in Chinese patients. This study aimed to evaluate the effectiveness and safety of ivabradine in Chinese patients with chronic HF.Methods and results This multicentre, single-arm, prospective, observational study enrolled Chinese patients with chronic HF. The primary outcome was change from baseline in HR at 1 and 6 months, measured by pulse counting. Effectiveness was also evaluated using laboratory tests, the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (CSS) and overall summary score (OSS), and New York Heart Association (NYHA) class. Treatment-emergent adverse events (TEAEs) were assessed. A post hoc analysis examined the effectiveness and safety of ivabradine combined with an angiotensin receptor-neprilysin inhibitor (ARNI) or beta-blocker. A total of 1003 patients were enrolled [mean age 54.4 +/- 15.0 years, 773 male (77.1%), mean baseline HR 88.5 +/- 11.3 b.p.m., mean blood pressure 115.7/74.4 +/- 17.2/12.3 mmHg, mean left ventricular ejection fraction 30.9 +/- 7.6%, NYHA Classes III and IV in 48.8% and 22.0% of patients, respectively]. HR decreased by a mean of 12.9 and 16.1 b.p.m. after 1 and 6 months, respectively (both P < 0.001). At Month 6, improvements in the KCCQ CSS and OSS of >= 5 points were observed in 72.1% and 74.1% of patients, respectively (both P < 0.001). Left ventricular ejection fraction increased by 12.1 +/- 11.6 (P < 0.001), and 66.7% of patients showed improvement in NYHA class (P < 0.001). At Month 6, the overall proportion of patients in NYHA Classes III and IV was reduced to 13.5% and 2.1%, respectively. Serum brain natriuretic peptide (BNP) and N-terminal pro-BNP changed by -331.9 ng/L (-1238.6, -134.0) and -1113.8 ng/L (-2202.0, -297.2), respectively (P < 0.001). HR reductions and improvements in NYHA and KCCQ scores with ivabradine were similar with and without use of ARNIs or beta-blockers. Of 498 TEAEs in 296 patients (29.5%), 73 TEAEs in 55 patients (5.5%) were considered related to ivabradine [most frequent sinus bradycardia (n = 7) and photopsia (n = 7)]. TEAEs were reported in a similar number of patients in ARNI and beta-blocker subgroups (21.9-35.6%).Conclusions Ivabradine treatment reduced HR and improved cardiac function and health-related quality of life in Chinese patients with chronic HF. Benefits were seen irrespective of whether or not patients were also taking ARNIs or beta-blockers. Treatment was well tolerated with a similar profile to previous ivabradine studies.
第一作者机构：[1]Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China
通讯作者：
通讯机构：[1]Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China[*1]hanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai 200032, China.
推荐引用方式(GB/T 7714)：
Jingmin Zhou,Yamei Xu,Zhaofen Zheng,et al.Effectiveness and safety of ivabradine in Chinese patients with chronic heart failure: an observational study[J].ESC HEART FAILURE.2024,11(2):846-858.doi:10.1002/ehf2.14581.
APA：
Jingmin Zhou,Yamei Xu,Zhaofen Zheng,Shuyang Zhang,Jiefu Yang...&Junbo Ge.(2024).Effectiveness and safety of ivabradine in Chinese patients with chronic heart failure: an observational study.ESC HEART FAILURE,11,(2)
MLA：
Jingmin Zhou,et al."Effectiveness and safety of ivabradine in Chinese patients with chronic heart failure: an observational study".ESC HEART FAILURE 11..2(2024):846-858
