Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction

Study Overview
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Brief Summary
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To elucidate the efficacy and safety of weixin decoction in the treatment of heart failure after myocardial infarction.

Detailed Description
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To elucidate the long-term protective effect of flavored Wenxin Decoction on heart failure after myocardial infarction. To elucidate the effective components in the treatment of heart failure and the mechanism of metabolism regulation.

Official Title
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Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction

Conditions
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Heart Failure, Myocardial Infarction

Intervention / Treatment
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* Drug: Modified Wenxin Decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old； A history of acute myocardial infarction； Cardiac function Ⅱ - Ⅲ level； LVEF 50% 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 of >; 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
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 modified Wenxin Tang granules, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks. | Drug: Modified Wenxin Decoction<br>* Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.<br>* Other names: placebo;|
| 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: Modified Wenxin Decoction<br>* Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular events | Rates of cardiac death, acute myocardial infarction, stroke, and heart failure readmission | One months after drug intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary indicators | NT-proBNP， six-minute walking experiment and echocardiographic | Into the group day 1, week 4, week 8, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese Medicine