Qishenyiqi for Ventricular Remodeling After Myocardial Infarction

November 20, 2024 updated by: Pan-Pan Hao, Qilu Hospital of Shandong University

Efficacy and Safety of Qishenyiqi Dripping Pills in Patients With Ventricular Remodeling and Chronic Heart Failure With Reduced Ejection Fraction After Myocardial Infarction

The effects of Qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of Qishenyiqi in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure after myocardial infarction were selected and randomly divided into two groups: the treatment group was treated with Qishenyiqi dripping pills; The control group was given placebo treatment. After 12 months of follow-up, the effects of Qishenyiqi on cardiac remodeling and function and cardiovascular adverse events were evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 4

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

Study Locations

  • China
      • Jinan, China
        • Jinan Central Hospital Affiliated to Shandong First Medical University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qianfoshan Hospital, Shandong University
      • Jinan, Shandong, China, 250012

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1) The history of acute myocardial infarction exceeds 3 months;
  • 2) Symptoms and signs of heart failure have been stable for more than one month;
  • 3) 18 years old or more;
  • 4) NYHA cardiac function classified as grade II~IV;
  • 5) LVEF≤40%；
  • 6) NT-proBNP≥450pg/ml；
  • 7) All subjects or their guardians must sign the subject consent before entering the trial.

Exclusion Criteria:

  • 1) Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
  • 2) Planned to undergo cardiac surgery within 12 months;
  • 3) Mechanical complications of myocardial infarction;
  • 4) Pregnant or nursing, or having the intention to give birth within one year;
  • 5) Patients who participated in clinical research of other drugs within 3 months before being selected;
  • 6) Patients with poor sound transmission windows are examined by transthoracic ultrasound.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo, 1 bag once, three times a day, 12 months
Experimental: Qishenyiqi
Drug: Qishenyiqi dripping pills
Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LVEDVI=LVEDV/BSA
Time Frame: From baseline to 12 months after follow-up
Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months
From baseline to 12 months after follow-up

Collaborators and Investigators

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

Sponsor

Qilu Hospital of Shandong University

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 (Estimated)

November 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qishenyiqi and HFrEF

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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