Liu Tong, Yao Sijie, Jiang Wei, Lan Taohua, Xu Wenjing, Cao Haiming, Yao Ping, Wang Chao, Lu Weihui, Chen Xiankun
State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Department of Cardiology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Front Cardiovasc Med. 2023 Jan 27;10:1103548. doi: 10.3389/fcvm.2023.1103548. eCollection 2023.
Xin-Li-Fang (XLF), a representative Chinese patent medicine, was derived from years of clinical experience by academician Chen Keji, and is widely used to treat chronic heart failure (CHF). However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XLF for CHF.
This multicenter, double-blinded RCT will be conducted in China. 300 eligible participants will be randomly assigned to either an XLF group or a control group at a 1:1 ratio. Participants in the XLF group will receive XLF granules plus routine care, while those in the control group will receive placebo granules plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the proportion of patients whose serum NT-proBNP decreased by more than 30%. The secondary outcomes include quality of life, the NYHA classification evaluation, 6-min walking test, TCM symptom evaluations, echocardiography parameters, and clinical events (including hospitalization for worsening heart failure, all-cause death, and other major cardiovascular events).
The results of the study are expected to provide evidence of high methodological and reporting quality on the efficacy and safety of XLF for CHF.
Chinese Clinical Trial Registration Center (www.chictr.org.cn). The trial was registered on 13 April 2022 (ChiCTR2200058649).
心力方（XLF）是一种具有代表性的中成药，源自陈可冀院士多年的临床经验，广泛用于治疗慢性心力衰竭（CHF）。然而，目前仍缺乏高质量证据支持临床决策。因此，我们设计了一项随机对照试验（RCT）来评估心力方治疗慢性心力衰竭的疗效和安全性。
本多中心、双盲RCT将在中国进行。300名符合条件的参与者将按1:1的比例随机分配至心力方组或对照组。心力方组参与者将接受心力方颗粒加常规护理，而对照组参与者将接受安慰剂颗粒加常规护理。研究周期为26周，包括2周的导入期、12周的治疗期和12周的随访期。主要结局是血清N末端脑钠肽前体（NT-proBNP）下降超过30%的患者比例。次要结局包括生活质量、纽约心脏协会（NYHA）分级评估、6分钟步行试验、中医症状评估、超声心动图参数以及临床事件（包括因心力衰竭恶化住院、全因死亡和其他主要心血管事件）。
该研究结果有望为心力方治疗慢性心力衰竭的疗效和安全性提供方法学和报告质量均较高的证据。
中国临床试验注册中心（www.chictr.org.cn）。该试验于2022年4月13日注册（ChiCTR2200058649）。
