Status:

UNKNOWN

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

Lead Sponsor:

Jun Li

Conditions:

Heart Failure

Myocardial Infarction

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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 a...

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 Ya...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 15 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2022

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04695990

Start Date

January 15 2021

End Date

December 30 2022

Last Update

January 6 2021

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