Qishenyiqi for Ventricular Remodeling After Myocardial Infarction

Shandong University

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Stable Heart Failure

Treatments: Drug: Qishenyiqi dripping pills; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06699407

Qishenyiqi and HFrEF

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups, including a placebo group

Qishenyiqi

Experimental group

Treatment:

Drug: Qishenyiqi dripping pills

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo