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

Jun Li

Status and phase: Unknown; Phase 2

Conditions: Myocardial Infarction; Heart Failure

Treatments: Drug: Modified Wenxin Decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT04667598

JWWX-2020

Details and patient eligibility

About

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

Full 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.

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 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.

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 modified Wenxin Tang granules, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.

Treatment:

Drug: Modified Wenxin 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: Modified Wenxin Decoction