Qishenyiqi for Ventricular Remodeling After Myocardial Infarction

NCT ID: NCT06699407

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2027-12-31

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.

Conditions

Chronic Stable Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Qishenyiqi

Group Type: EXPERIMENTAL

Qishenyiqi dripping pills

Intervention Type: DRUG

Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 1 bag once, three times a day, 12 months

Interventions

Qishenyiqi dripping pills

Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

Intervention Type: DRUG

Placebo

Placebo, 1 bag once, three times a day, 12 months

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Pan-Pan Hao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Panpan Hao

Jinan, Shandong, China

Qianfoshan Hospital, Shandong University

Jinan, Shandong, China

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, , China

Countries

China

Central Contacts

Panpan Hao

Role: CONTACT

panda.how@sdu.edu.cn

18560086593

Facility Contacts

Panpan Hao

Role: primary

panda.how@sdu.edu.cn

18560086593

Other Identifiers

Qishenyiqi and HFrEF

Identifier Type: -

Identifier Source: org_study_id