Overview

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

Status:
Not yet recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jun Li
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.