Effects of Guanxinshutong Capsules as Complementary Treatment in Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial

Yu Wang; Jiaping Xu; Jiehong Yang; Ling Zhang; Yuanjiang Pan; Liping Dou; Peng Zhou; Yizhou Xu; Chang Li; Yu He; Huifen Zhou; Li Yu; Jingwen Chen; Shuwei Huang; Wei Fu; Haitong Wan

doi:10.3389/fphar.2020.571106

Effects of Guanxinshutong Capsules as Complementary Treatment in Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial

Front Pharmacol. 2021 Jan 14:11:571106. doi: 10.3389/fphar.2020.571106. eCollection 2020.

Authors

Yu Wang¹, Jiaping Xu¹, Jiehong Yang², Ling Zhang¹, Yuanjiang Pan³, Liping Dou⁴, Peng Zhou⁵, Yizhou Xu⁶, Chang Li¹, Yu He⁷, Huifen Zhou¹, Li Yu¹, Jingwen Chen⁴, Shuwei Huang⁴, Wei Fu⁸, Haitong Wan¹

Affiliations

¹ Institute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, China.
² School of Basic Medicine and Public Health, Zhejiang Chinese Medical University, Hangzhou, China.
³ Department of Chemistry, Zhejiang University, Hangzhou, China.
⁴ Department of Cardiology, Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
⁵ Institute of Brain and Heart CO Treatment, Zhejiang Chinese Medical University, Hangzhou, China.
⁶ Department of Cardiology, Hangzhou First People's Hospital, Hangzhou, China.
⁷ School of Pharmacy, Zhejiang Chinese Medical University, Hangzhou, China.
⁸ Department of Cardiac-Cerebral Diseases, Yinchuan Cardiac-Cerebral Treatment Internet Hospital, Yinchuan, China.

Abstract

Chronic heart failure (CHF) is a common cardiovascular disease with high mortality and a poor prognosis, which places heavy burdens upon society and families. Traditional Chinese medicine (TCM) has been used extensively as complementary treatment for CHF. Guanxinshutong (GXST) capsules are used commonly for the treatment of coronary heart disease (CHD). Experimental research and small-sample clinical trials have shown that GXST can attenuate CHF. However, the effects of GXST as complementary medicine in CHF treatment lack high-quality clinical evidence. We have designed a multicenter, randomized, double-blind, placebo-controlled clinical trial that explores the efficacy and safety of using GXST compared with placebo for patients with CHF with reduced left ventricular ejection fraction (LVEF). A total of 480 participants will be assigned randomly to the GXST group or placebo group at a 2:1 ratio. GXST and placebo will be added to standard treatment for 12 weeks, and then followed up for another 40 weeks. The primary outcome is the improvement value of 6-min walk distance, and the secondary outcomes include plasma levels of N-terminal pro-B-type natriuretic peptide, New York Heart Association classification, Minnesota Living with Heart Failure Questionnaire scores, echocardiographic parameters, and clinical endpoint events. Adverse events will be monitored throughout the trial. Data will be analyzed following a predefined statistical analysis plan. This study will show the effects of the specific use of GXST in CHF patients with reduced LVEF. The Research Ethics Committee of the Second Affiliated Hospital of Zhejiang Chinese Medical University has approved this study (2019-Y-003-02). Written informed consent of patients will be required. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR1900023877). Our results will be disseminated to the public through peer-reviewed journals, academic conferences, and the Internet.

Keywords: Guanxinshutong (GXST); clinical trial; complementary medicine; heart failure; traditional Chinese medicine (TCM).