MedPath

Qishenyiqi for Ventricular Remodeling After Myocardial Infarction

Phase 4
Not yet recruiting
Conditions
Chronic Stable Heart Failure
Interventions
Drug: Qishenyiqi dripping pills
Drug: Placebo
Registration Number
NCT06699407
Lead Sponsor
Qilu Hospital of Shandong University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
210
Inclusion Criteria
    1. The history of acute myocardial infarction exceeds 3 months;
    1. Symptoms and signs of heart failure have been stable for more than one month;
    1. 18 years old or more;
    1. NYHA cardiac function classified as grade II~IV;
    1. LVEF≤40%;
    1. NT-proBNP≥450pg/ml;
    1. All subjects or their guardians must sign the subject consent before entering the trial.
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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;
    1. Planned to undergo cardiac surgery within 12 months;
    1. Mechanical complications of myocardial infarction;
    1. Pregnant or nursing, or having the intention to give birth within one year;
    1. Patients who participated in clinical research of other drugs within 3 months before being selected;
    1. Patients with poor sound transmission windows are examined by transthoracic ultrasound.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
QishenyiqiQishenyiqi dripping pills-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
LVEDVI=LVEDV/BSAFrom baseline to 12 months after follow-up

Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Panpan Hao

🇨🇳

Jinan, Shandong, China

Qianfoshan Hospital, Shandong University

🇨🇳

Jinan, Shandong, China

Jinan Central Hospital Affiliated to Shandong First Medical University

🇨🇳

Jinan, China

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