Qishenyiqi for Ventricular Remodeling After Myocardial Infarction

NCT06699407 | Not Yet Recruiting Phase 4

• 1 other identifier: Qishenyiqi and HFrEF
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• LVEDVI=LVEDV/BSA

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

  From baseline to 12 months after follow-up

Study Arms (2)

Qishenyiqi

EXPERIMENTAL

Drug: Qishenyiqi dripping pills

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Qishenyiqi dripping pills DRUG

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

Qishenyiqi

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) 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;
• \) Planned to undergo cardiac surgery within 12 months;
• \) Mechanical complications of myocardial infarction;
• \) Pregnant or nursing, or having the intention to give birth within one year;
• \) Patients who participated in clinical research of other drugs within 3 months before being selected;
• \) Patients with poor sound transmission windows are examined by transthoracic ultrasound.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (3)

Panpan Hao

Jinan, Shandong, 250012, China

Location

Qianfoshan Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, China

Location

Central Study Contacts

Panpan Hao

CONTACT

18560086593; panda.how@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

CN (3)