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

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

doi:10.3389/fphar.2020.571106

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.

Highlights

Chronic heart failure (CHF) is a complex clinical syndrome characterized by reduced cardiac output, insufficient organ perfusion, and venous congestion due to cardiac dysfunction (Coronel et al, 2001; Tan et al, 2010)
An increasing volume of evidence demonstrates that the combination of Traditional Chinese medicine (TCM) with Western medicine could be an optimal approach for achieving greater treatment efficacy in patients with CHF (Gao et al, 2017; Jia et al, 2020)
Pharmacology results have shown the effects of GXST in multiple mechanism pathways to treat CHF, such as improving hemorheology (Liang et al, 2012); enhancing mitochondrial capacity, and improving myocardial energy metabolism (Zhang et al, 2015; Zhang et al, 2016); and reversing ventricular remodeling (Zhang et al, 2012; Zhang et al, 2013)

Summary

INTRODUCTION

Chronic heart failure (CHF) is a complex clinical syndrome characterized by reduced cardiac output, insufficient organ perfusion, and venous congestion due to cardiac dysfunction (Coronel et al, 2001; Tan et al, 2010). According to guidelines for the diagnosis and treatment of heart failure set by the Chinese government in 2018, angiotensin-converting enzyme inhibitors (ACEIs), β-receptor blockers, and aldosterone receptor antagonists are recommended as “the golden triangle treatment” for patients suffering from CHF with reduced ejection fraction (Heart Failure Group of Chinese Society of Cardiology and Editorial Board of Chinese Journal of Cardiology, 2018). A clinical trial with 61 patients reported that, compared with conventional treatment, combination with GXST could significantly increase left ventricular ejection fraction (LVEF) and cardiac output, and reduce the end-systolic, diastolic volume in patients with acute myocardial infarction with CHF (Li, 2019). The primary hypothesis of this study is as follows: combined with routine standard treatment, GXST is superior to placebo in patients with reduced LVEF caused by CHD. Dried ripe fruit Dried root and rhizome Dried flower bud Essential oil Dried mass of secretion

Design and Settings

DISCUSSION

Methods of analyses

Findings

ETHICS STATEMENT