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

Jun Li

Status and phase: Unknown; Phase 2

Conditions: Myocardial Infarction; Heart Failure

Treatments: Drug: Wenyang Huoxue Decoction; Drug: Wenyang Huoxue placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04695990

wyhx-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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.

Treatment:

Drug: Wenyang Huoxue Decoction

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Wenyang Huoxue placebo