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

被引：0

作者：

Feng, Lina ^{[1
,2
]}

Chen, Sizhen ^{[1
,3
]}

Liu, Jiang ^{[1
,2
]}

Li, Chunyan ^{[4
]}

Cao, Hongshuai ^{[1
]}

Tao, Liyuan ^{[5
]}

Fang, Fang ^{[6
]}

Huo, Feijiao ^{[7
]}

Liu, Lingling ^{[8
]}

Wubu'er, Palidan ^{[9
]}

Wang, Ming ^{[9
]}

Zhao, Xiaohua ^{[9
]}

Liu, Xiaojian ^{[10
]}

Xin, Hui ^{[11
]}

Li, Ding ^{[12
]}

Mao, Weisheng ^{[13
]}

Gui, Liang ^{[14
]}

Guan, Jianfei ^{[15
]}

Zhu, Zhiyang ^{[16
]}

Song, Haijun ^{[17
]}

Li, Shi ^{[18
]}

Song, Yingjing ^{[19
]}

Shi, Meiling ^{[20
]}

Zhang, Chao ^{[21
]}

Zhang, Zhiying ^{[22
]}

Li, Huiyun ^{[23
]}

Wang, Xiaobin ^{[24
]}

Yang, Baolong ^{[25
]}

Jin, Zhao ^{[26
]}

Du, Yifei ^{[1
]}

Gao, Yonghui ^{[1
]}

Cao, Lulei ^{[1
]}

Yang, Jiamei ^{[1
]}

Wang, Qiao ^{[1
]}

Kang, Naidan ^{[1
]}

Su, Lina ^{[1
]}

Zheng, Zhaoqi ^{[1
,2
]}

Fan, Jiasai ^{[3
]}

Xu, Jiaying ^{[1
]}

Shi, Zaixiang ^{[4
]}

Ren, Jingyi ^{[1
]}

SHINE HF Investigator

机构：

[1] China Japan Friendship Hosp, Heart Failure Ctr, Dept Cardiol, Beijing 10029, Peoples R China

[2] Peking Univ, China Japan Friendship Sch Clin Med, Beijing 100029, Peoples R China

[3] Beijing Univ Chinese Med, China Japan Friendship Hosp, Beijing 10029, Peoples R China

[4] China Japan Friendship Hosp, Dept Cardiol Integrated Tradit Chinese & Western M, 2 Yinghua Dongjie, Beijing 100029, Peoples R China

[5] Peking Univ Third Hosp, Res Ctr Clin Epidemiol, Beijing 100191, Peoples R China

[6] China Japan Friendship Hosp, Off Hosp Reform & Hosp Dev, Beijing 100029, Peoples R China

[7] Gongyi City Publ Hosp TCM, Gongyi 451200, Peoples R China

[8] Beijing Fengtai Hosp Integrated Tradit Chinese & W, Beijing 100071, Peoples R China

[9] Urumqi Hosp Tradit Chinese Med, Urumqi 830000, Peoples R China

[10] Changzhi Med Coll, Affiliated Heji Hosp, Changzhi 046000, Peoples R China

[11] Qingdao Univ, Affiliated Hosp, Qingdao 266071, Peoples R China

[12] Peking Univ Peoples Hosp, Beijing 100044, Peoples R China

[13] Xinyuan Tradit Chinese Med Hosp, Urumqi 835800, Peoples R China

[14] Changji Hosp Tradit Chinese Med, Urumqi 835800, Peoples R China

[15] Tang Cty Hosp Tradit Chinese Med, Baoding 072350, Peoples R China

[16] Jining Hosp Tradit Chinese Med, Jining 272004, Peoples R China

[17] Changzhi Inst Tradit Chinese Med, Affiliated Hosp, Changzhi 046000, Peoples R China

[18] Funing Hosp Tradit Chinese Med, Qinhuangdao 066399, Peoples R China

[19] Linhai Hosp Tradit Chinese Med, Linhai 317000, Peoples R China

[20] Changzhi Hosp Tradit Chinese Med, Changzhi 046099, Peoples R China

[21] Zhaosu Hosp Tradit Chinese Med, Zhaosu 654126, Ili Kazakh Auto, Peoples R China

[22] Yining Hosp Tradit Chinese Med, Yining 835100, Ili Kazakh Auto, Peoples R China

[23] Korla Hosp Tradit Chinese Med, Korla 841000, Ili Kazakh Auto, Peoples R China

[24] Yangzhou Hosp Tradit Chinese Med, Yangzhou 225127, Peoples R China

[25] Jixian Chinese Tradit Hosp, Tianjin 301900, Peoples R China

[26] Changping Dist Tradit Chinese Med Hosp, Beijing 102208, Peoples R China

来源：

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS | 2025年 / 45卷

关键词：

Heart failure with reduced and mildly-reduced ejection fraction; Complementary and alternative medicine; Traditional Chinese medicine; ShengXian-QuYu decoction; Kansas city cardiomyopathy questionnaire; CITY CARDIOMYOPATHY QUESTIONNAIRE; SHENGJIE TONGYU DECOCTION; QUALITY-OF-LIFE; PLACEBO;

D O I：

10.1016/j.conctc.2025.101497

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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 doubleblind 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.

引用

页数：10

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