Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction

Phase 2

• Conditions: Heart Failure; Myocardial Infarction
• Interventions: Drug: Wenyang Huoxue Decoction; Drug: Wenyang Huoxue placebo

• Registration Number: NCT04695990
• Lead Sponsor: Jun Li

Brief Summary

This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in a Chinese population with heart failure after myocardial infarction. The objective is to observe the efficacy and safety of Wenyang huoxue fang in the treatment of heart failure after myocardial infarction.

Detailed Description

Currently, there is a lack of high-quality evidence-based support for TCM treatment of heart failure after myocardial infarction. In addition, previous studies have found that the method of warming Yang and activating blood circulation is effective in treating coronary heart disease, and the core pathogenesis of heart failure after myocardial infarction is also Yang deficiency and blood stasis. Therefore, this project aims to evaluate the clinical value of warming Yang and activating blood circulation in the treatment of heart failure after myocardial infarction. Through pharmacological research and detection, the efficacy of Wenyang huoxue prescription in heart failure rats after intervention of myocardial infarction was evaluated, mir-233-ISO signaling pathway was detected before and after treatment, and its mechanism of action was further clarified from the perspective of epigenetics and classical pathway of heart failure.

Objective To investigate the efficacy and safety of Wenyang Huoxue fang in the treatment of heart failure after myocardial infarction.

Study Timeline

• Study First Submitted: 2020-11-29
• Status Verified: 2020-12
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-06
• Last Update Posted: 2021-01-06
• Study Start: 2021-01-15
• Primary Completion: 2022-03-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18-75 years old;
• A history of acute myocardial infarction;
• Cardiac function grade II-IV;
• LVEF 40% or less; NT-proBNP level ≥ 450 pg/mL; -All men and women can sign the informed consent form.-

Exclusion Criteria

• Coronary artery bypass grafting was performed within 12 weeks.
• Undergo or possibly undergo cardiac resynchronization therapy;
• Primary valvular disease, left ventricular outflow tract obstruction, myocarditis, aneurysm, uncontrolled severe arrhythmia, cardiogenic shock, unstable angina pectoris, or acute myocardial infarction;
• Having a serious primary liver, kidney or blood system disease or having a serious mental illness or a systemic disease that is out of control;
• Serum creatinine > 194.5 mol/L or serum potassium > 5.5mmol /L;
• The level of alanine aminotransferase or alkaline phosphatase is 1.5 times of the normal upper limit ;
• Abnormal blood pressure control, systolic blood pressure exceeding 180mmHg or diastolic blood pressure exceeding 110mmHg;
• Pregnancy or lactation;
• Known or suspected allergy to research drugs;
• To receive another investigational drug within 30 days of randomization or to be unwilling or unable to provide written consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Wenyang Huoxue Decoction	On the basis of basic western medicine treatment (secondary prevention of coronary heart disease + anti-heart failure treatment), Patients in this group will be given Wenyang Huoxue Decoction, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.
Control group	Wenyang Huoxue placebo	On the basis of basic western medicine treatment (secondary prevention of coronary heart disease + anti-heart failure treatment), Patients in this group will be given placebo, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Major cardiovascular events	One months to 1 year after drug intervention	The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization

Secondary Outcome Measures

Name	Time	Method
Main observation indicators	Into the group day 1, week 4, week 8, week 12	The numerical of NT-proBNP
Secondary observation index	Into the group day 1, week 4, week 8, week 12	The Left ventricular ejection fractione of chocardiography