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

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure, Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Wenyang Huoxue Decoction
* Drug: Wenyang Huoxue placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Drug: Wenyang Huoxue Decoction<br>* Wenyang Huoxue granules<br>* Other names: WYHX;|
| Placebo Comparator: Control group<br>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. | Drug: Wenyang Huoxue placebo<br>* Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.<br>* Other names: WYHX placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular events | The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization | One months to 1 year after drug intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main observation indicators | The numerical of NT-proBNP | Into the group day 1, week 4, week 8, week 12 | 
| Secondary observation index | The Left ventricular ejection fractione of chocardiography | Into the group day 1, week 4, week 8, week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wenyang Huoxue decoction