Clinical trial NCT04695990: Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction
Official title: Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure
Myocardial Infarction
Keywords: Wenyang Huoxue decoction
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and safety of Wenyang huoxue fang in the treatment of heart failure after myocardial infarction.

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 Yang and activating blood circulation is effective in treating coronary heart disease, and the core pathogenesis of heart failure after myocardial infarction is also Yang deficiency and blood stasis. Therefore, this project aims to evaluate the clinical value of warming Yang and activating blood circulation in the treatment of heart failure after myocardial infarction. Through pharmacological research and detection, the efficacy of Wenyang huoxue prescription in heart failure rats after intervention of myocardial infarction was evaluated, mir-233-ISO signaling pathway was detected before and after treatment, and its mechanism of action was further clarified from the perspective of epigenetics and classical pathway of heart failure.

Objective To investigate the efficacy and safety of Wenyang Huoxue fang in the treatment of heart failure after myocardial infarction.

Eligibility 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.

Primary outcomes:
measure: Major cardiovascular events
timeFrame: One months to 1 year after drug intervention
Secondary outcomes:
measure: Main observation indicators
timeFrame: Into the group day 1, week 4, week 8, week 12
measure: Secondary observation index
timeFrame: Into the group day 1, week 4, week 8, week 12
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jun Li, MD
role: STUDY_DIRECTOR
References:
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citation: Ezekowitz JA, Kaul P, Bakal JA, Armstrong PW, Welsh RC, McAlister FA. Declining in-hospital mortality and increasing heart failure incidence in elderly patients with first myocardial infarction. J Am Coll Cardiol. 2009 Jan 6;53(1):13-20. doi: 10.1016/j.jacc.2008.08.067.