Heart Failure, Myocardial Infarction
Conditions
Keywords
Wenyang Huoxue decoction
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.
Interventions
DRUGWenyang Huoxue Decoction
Wenyang Huoxue granules
DRUGWenyang Huoxue placebo
Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.
Sponsors
Jun Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiovascular events | One months to 1 year after drug intervention | The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main observation indicators | Into the group day 1, week 4, week 8, week 12 | The numerical of NT-proBNP |
| Secondary observation index | Into the group day 1, week 4, week 8, week 12 | The Left ventricular ejection fractione of chocardiography |
Contacts
Primary ContactJun Li, MD
Outcome results
None listed