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BMC Complementary Medicine and Therapies

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01-12-2020 | Heart Failure | Study protocol

Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)

Authors: Wenming Yao, Iokfai Cheang, Shengen Liao, Yanli Zhou, Fang Zhou, Dongjie Xu, Zhenhua Jia, Liping Chang, Haifeng Zhang, Xinli Li

Published in: BMC Complementary Medicine and Therapies | Issue 1/2020

Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

The trial was registered at http://www.chictr.org.cn. ( Registration No.: ChiCTR1900021929); Date: 2019-03-16.

Available only for authorised users

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Title: Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)
Authors: Wenming Yao
Iokfai Cheang
Shengen Liao
Yanli Zhou
Fang Zhou
Dongjie Xu
Zhenhua Jia
Liping Chang
Haifeng Zhang
Xinli Li
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Heart Failure
Chronic Heart Failure
Published in: BMC Complementary Medicine and Therapies / Issue 1/2020
Electronic ISSN: 2662-7671
DOI: https://doi.org/10.1186/s12906-020-2821-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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