Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction

December 8, 2020 updated by: Jun Li
To elucidate the efficacy and safety of weixin decoction in the treatment of heart failure after myocardial infarction.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To elucidate the long-term protective effect of flavored Wenxin Decoction on heart failure after myocardial infarction.

To elucidate the effective components in the treatment of heart failure and the mechanism of metabolism regulation.

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 Ⅱ - Ⅲ level；
  • LVEF 50% 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 of >;
  • 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
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 modified Wenxin Tang granules, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.
Drug: Modified Wenxin Decoction
Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.
Other Names:
  • placebo
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: Modified Wenxin Decoction
Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major cardiovascular events
Time Frame: One months after drug intervention
Rates of cardiac death, acute myocardial infarction, stroke, and heart failure readmission
One months after drug intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary indicators
Time Frame: Into the group day 1, week 4, week 8, week 12
NT-proBNP， six-minute walking experiment and echocardiographic
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

Investigators

  • Study Director: Jun Li, MD, Guang 'anmen Hospital of China Academy of Chinese Medical Sciences

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)

December 15, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 8, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWWX-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.

Clinical Trials on Myocardial Infarction

Clinical Trials on Modified Wenxin Decoction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe