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

NCT ID: NCT04695990

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2022-12-30

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.

Conditions

Heart Failure; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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 Wenyang Huoxue Decoction, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.

Group Type: EXPERIMENTAL

Wenyang Huoxue Decoction

Intervention Type: DRUG

Wenyang Huoxue granules

Control group

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.

Group Type: PLACEBO_COMPARATOR

Wenyang Huoxue placebo

Intervention Type: DRUG

Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.

Interventions

Wenyang Huoxue Decoction

Wenyang Huoxue granules

Intervention Type: DRUG

Wenyang Huoxue placebo

Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.

Intervention Type: DRUG

Other Intervention Names

WYHX; WYHX placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jun Li

OTHER

Sponsor Role: lead

Responsible Party

Jun Li

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jun Li, MD

Role: STUDY_DIRECTOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Central Contacts

Jun Li, MD

Role: CONTACT

gamyylj@163.com

13051458913

References

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Reference Type: RESULT

PMID: 29386200 (View on PubMed)

Hildebrandt P. Systolic and nonsystolic heart failure: equally serious threats. JAMA. 2006 Nov 8;296(18):2259-60. doi: 10.1001/jama.296.18.2259. No abstract available.

Reference Type: RESULT

PMID: 17090774 (View on PubMed)

Gheorghiade M, Bonow RO. Chronic heart failure in the United States: a manifestation of coronary artery disease. Circulation. 1998 Jan 27;97(3):282-9. doi: 10.1161/01.cir.97.3.282. No abstract available.

Reference Type: RESULT

PMID: 9462531 (View on PubMed)

Gerber Y, Melton LJ 3rd, Weston SA, Roger VL. Association between myocardial infarction and fractures: an emerging phenomenon. Circulation. 2011 Jul 19;124(3):297-303. doi: 10.1161/CIRCULATIONAHA.110.007195. Epub 2011 Jun 27.

Reference Type: RESULT

PMID: 21709062 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19118718 (View on PubMed)

Other Identifiers

wyhx-2020

Identifier Type: -

Identifier Source: org_study_id