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

Phase 2

• Conditions: Heart Failure; Myocardial Infarction
• Interventions: Drug: Modified Wenxin Decoction

• Registration Number: NCT04667598
• Lead Sponsor: Jun Li

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-11-23
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-08
• Last Update Submitted: 2020-12-08
• Study First Posted: 2020-12-14
• Last Update Posted: 2020-12-14
• Study Start: 2020-12-15
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Modified Wenxin 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 modified Wenxin Tang granules, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.
Control group	Modified Wenxin 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 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 after drug intervention	Rates of cardiac death, acute myocardial infarction, stroke, and heart failure readmission

Secondary Outcome Measures

Name	Time	Method
Secondary indicators	Into the group day 1, week 4, week 8, week 12	NT-proBNP， six-minute walking experiment and echocardiographic