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

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 incide...

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Autores principales: Yao, Wenming, Cheang, Iokfai, Liao, Shengen, Zhou, Yanli, Zhou, Fang, Xu, Dongjie, Jia, Zhenhua, Chang, Liping, Zhang, Haifeng, Li, Xinli
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076750/
https://www.ncbi.nlm.nih.gov/pubmed/32024496
http://dx.doi.org/10.1186/s12906-020-2821-0
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author Yao, Wenming
Cheang, Iokfai
Liao, Shengen
Zhou, Yanli
Zhou, Fang
Xu, Dongjie
Jia, Zhenhua
Chang, Liping
Zhang, Haifeng
Li, Xinli
author_facet Yao, Wenming
Cheang, Iokfai
Liao, Shengen
Zhou, Yanli
Zhou, Fang
Xu, Dongjie
Jia, Zhenhua
Chang, Liping
Zhang, Haifeng
Li, Xinli
author_sort Yao, Wenming
collection PubMed
description 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.
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spelling pubmed-70767502020-03-19 Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST) Yao, Wenming Cheang, Iokfai Liao, Shengen Zhou, Yanli Zhou, Fang Xu, Dongjie Jia, Zhenhua Chang, Liping Zhang, Haifeng Li, Xinli BMC Complement Med Ther Study Protocol 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. BioMed Central 2020-02-05 /pmc/articles/PMC7076750/ /pubmed/32024496 http://dx.doi.org/10.1186/s12906-020-2821-0 Text en © The Author(s). 2020 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Yao, Wenming
Cheang, Iokfai
Liao, Shengen
Zhou, Yanli
Zhou, Fang
Xu, Dongjie
Jia, Zhenhua
Chang, Liping
Zhang, Haifeng
Li, Xinli
Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)
title Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)
title_full Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)
title_fullStr Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)
title_full_unstemmed Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)
title_short Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST)
title_sort study protocol for a randomized controlled trial: qiliqiangxin in heart failure: assessment of reduction in mortality (quest)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076750/
https://www.ncbi.nlm.nih.gov/pubmed/32024496
http://dx.doi.org/10.1186/s12906-020-2821-0
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