Department of Cardiology, the First Affiliated Hospital with Nanjing Medical University, Guangzhou Road 300, Nanjing, 210029, China.
National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, China.
BMC Complement Med Ther. 2020 Feb 5;20(1):38. doi: 10.1186/s12906-020-2821-0.
Qiliqiangxin (QLQX) capsule is a Traditional Chinese Medicine (TCM) that has been approved in China for the treatment of chronic heart failure (CHF). Our previous study showed with a background of standard HF treatment, QLQX capsules further reduced the levels of NT-proBNP and the incidence of composite cardiac events (CCEs) in CHF patients. This study aims to further assess the reduction in mortality when using QLQX compared with placebo for heart failure with reduced ejection fraction (HFrEF) patients.
This study is a randomized, double-blind, placebo-controlled, parallel-group, multi-center, event-driven clinical study of approximately 3080 patients for a targeted 620 events. Patients must have a diagnosis of heart failure for at least 3 months prior to screening. Patients will be randomized 1:1 to receive the placebo or QLQX in addition to their standard medications of CHF. The primary efficacy outcome event is a composite cardiovascular death and re-hospitalization due to the worsening of heart failure.
The QUEST study is a randomized control study of TCM in chronic heart failure. It will determine the place of QLQX as an new treatment approach and provide additional and innovative information regarding TCM - and the specific used of QLQX in HFrEF.
The trial was registered at http://www.chictr.org.cn. ( Registration No.: ChiCTR1900021929); Date: 2019-03-16.
芪苈强心胶囊是一种中药，已在中国获批用于治疗慢性心力衰竭（CHF）。我们之前的研究表明，在标准 HF 治疗的基础上，芪苈强心胶囊进一步降低了 CHF 患者的 NT-proBNP 水平和复合心脏事件（CCEs）的发生率。本研究旨在进一步评估与安慰剂相比，芪苈强心胶囊在射血分数降低的心力衰竭（HFrEF）患者中的死亡率降低情况。
这是一项随机、双盲、安慰剂对照、平行组、多中心、事件驱动的临床试验，大约有 3080 名患者，目标事件为 620 例。患者在筛选前必须有至少 3 个月的心力衰竭诊断。患者将以 1:1 的比例随机接受安慰剂或芪苈强心胶囊，同时接受心力衰竭的标准药物治疗。主要疗效终点事件是心血管死亡的复合终点和心力衰竭恶化导致的再住院。
QUEST 研究是一项关于慢性心力衰竭的中药随机对照研究。它将确定芪苈强心胶囊作为一种新的治疗方法的地位，并提供关于中药的额外和创新信息，以及在 HFrEF 中使用芪苈强心胶囊的具体信息。
该试验在中国临床试验注册中心注册。（注册号：ChiCTR1900021929）；日期：2019 年 3 月 16 日。
