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

January 4, 2021 updated by: Jun Li
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: Wenyang Huoxue placebo
Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.
Other Names:
  • WYHX placebo
Experimental: 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.
Drug: Wenyang Huoxue Decoction
Wenyang Huoxue granules
Other Names:
  • WYHX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major cardiovascular events
Time Frame: One months to 1 year after drug intervention
The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization
One months to 1 year after drug intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main observation indicators
Time Frame: Into the group day 1, week 4, week 8, week 12
The numerical of NT-proBNP
Into the group day 1, week 4, week 8, week 12
Secondary observation index
Time Frame: Into the group day 1, week 4, week 8, week 12
The Left ventricular ejection fractione of chocardiography
Into the group day 1, week 4, week 8, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Li

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

November 29, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wyhx-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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