SHengXIaN-QuYu DEcoction in the Treatment of Heart Failure with Reduced and Mildly-Reduced Ejection Fraction (SHINE-HF): rationale and design for a multicenter randomized controlled trial

SHengXIaN-QuYu DEcoction in the Treatment of Heart Failure with Reduced and Mildly-Reduced Ejection Fraction (SHINE-HF): rationale and design for a multicenter randomized controlled trial

Background: Although contemporary guideline-directed medical therapy (GDMT) for heart failure (HF) with reduced ejection fraction (HFrEF) and heart failure with mildly-reduced ejection fraction (HFmrEF) has been shown to significantly improve prognosis, patients with these conditions still face cons...

Full description

Saved in:
Bibliographic Details
Main Authors: Lina Feng, Sizhen Chen, Jiang Liu, Chunyan Li, Hongshuai Cao, Liyuan Tao, Fang Fang, Feijiao Huo, Lingling Liu, Palidan Wubu'er, Ming Wang, Xiaohua Zhao, Xiaojian Liu, Hui Xin, Ding Li, Weisheng Mao, Liang Gui, Jianfei Guan, Zhiyang Zhu, Haijun Song, Shi Li, Yingjing Song, Meiling Shi, Chao Zhang, Zhiying Zhang, Huiyun Li, Xiaobin Wang, Baolong Yang, Zhao Jin, Yifei Du, Yonghui Gao, Lulei Cao, Jiamei Yang, Qiao Wang, Naidan Kang, Lina Su, Zhaoqi Zheng, Jiasai Fan, Jiaying Xu, Zaixiang Shi, Jingyi Ren
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Contemporary Clinical Trials Communications
Subjects:
Heart failure with reduced and mildly-reduced ejection fraction
Complementary and alternative medicine
Traditional Chinese medicine
ShengXian-QuYu decoction
Kansas city cardiomyopathy questionnaire
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865425000717
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Background: Although contemporary guideline-directed medical therapy (GDMT) for heart failure (HF) with reduced ejection fraction (HFrEF) and heart failure with mildly-reduced ejection fraction (HFmrEF) has been shown to significantly improve prognosis, patients with these conditions still face considerable residual risk, and their quality of life (QoL) remains severely compromised. ShengXian-QuYu (SXQY) Decoction is a widely prescribed complementary and alternative medicine (CAM) therapy for HF in clinical practice. However, there is currently no robust evidence supporting its efficacy in HFrEF and HFmrEF, and its potential adverse effects have yet to be fully elucidated. Methods: Patients with chronic HF, New York Heart Association (NYHA) class II–IV symptoms, elevated plasma natriuretic peptide levels, and a left ventricular ejection fraction (LVEF) of ≤50 % were enrolled in the ShengXian-QuYu Decoction in the Treatment of Heart Failure with Reduced and mildly reduced Ejection Fraction (SHINE-HF) trial. Patients eligibility entered a run-in period, followed by randomization in a 1:1 ratio to double-blind treatment with either 30 ml of SXQY or 30 ml of placebo, administered twice daily. The primary endpoint was the change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at week 12. Key secondary endpoints included the change from baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) and the 6-min walk test (6MWT) distance at week 12. Additionally, a safety analysis will be conducted. Conclusion: SHINE-HF will determine the effects of SXQY on patient-reported outcomes (PROs) and symptom burden in patients with HFrEF and HFmrEF. This will shed light on the potential of SXQY as a novel treatment option in improving QoL of patients with HFrEF and HFmrEF.
ISSN:2451-8654

Similar Items