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

Jun Li200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Heart Failure Myocardial Infarction

Interventions

Wenyang Huoxue DecoctionDRUG

Wenyang Huoxue granules

Wenyang Huoxue placeboDRUG

Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Major cardiovascular events

The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization

Time frame: One months to 1 year after drug intervention

Secondary Outcomes

Main observation indicators

The numerical of NT-proBNP

Time frame: Into the group day 1, week 4, week 8, week 12

Secondary observation index

The Left ventricular ejection fractione of chocardiography

Time frame: Into the group day 1, week 4, week 8, week 12

Central Contacts

Jun Li, MD

CONTACT

13051458913 gamyylj@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.