Chronic Heart failure (CHF) is a global epidemic and common cardiovascular disease with high mortality and poor prognosis, which bring heavy burdens to society and family. Traditional Chinese medicine (TCM) has been extensively used in China as an adjunct treatment for CHF. Guanxinshutong capsule (GXST), approved by the China Food and Drug Administration (CFDA) in 2002 (No. Z20020055), is commonly used Chinese herbal medicine (CHM) for the treatment of coronary heart disease (CHD) currently. Both experimental research and small-sample clinical trials have shown that GXST could attenuate CHF. However, the effects of GXST on CHF as an adjunct therapy are lack of high-quality clinical evidence. This study is a large-scale, multi-center, double-blinded clinical trial to explore the efficacy and safety of GXST in CHF with ejection fraction decrease (<50%) caused by CHD.
This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. After 1week baseline period, a total of 480 participants will be randomly assigned to the intervention group and placebo group in ratio 2:1. Based on routine medications, the intervention group will be treated with GXST while the control group will be treated with placebo (both 0.3g/capsule, op, 3 capsules/time, thrice daily) for 12 weeks, and then be followed-up for another 40 weeks. The primary outcome is the effect of 6 min walk test (6MWT). The secondary outcomes include NT-proBNP, classification of the New York Heart Association (NYHA) heart function, Minnesota heart failure quality of life scale (MLHFQ), echocardiographic parameters, blood stasis syndrome symptom scale and clinical endpoint events. Metabolomics and proteomics will also be assessed. Adverse events (AEs) will be monitored throughout the trial. All the data will be recorded in electronic case report forms (eCRF) system database and analyzed in accordance with a predefined statistical analysis plan. Ethical approval of this trial has been granted by the Research Ethics Committee of the Second Affiliated Hospital of Zhejiang Chinese Medical University (ID: 2019-Y-003-02). Written informed consent of patients will be required. The results will be disseminated to the public through peer-reviewed journals and academic conferences.
This study integrates the advantages of TCM and western medicine in the treatment of CHF, the result of this study will offer the efficacy and safety evidence of GXST on CHF with ejection fraction decrease (<50%).