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Clinical Trials in China / NCT06699407
Starting soon Phase 4

Qishenyiqi for Ventricular Remodeling After Myocardial Infarction

NCT06699407 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Phase 4
Started
2024-11-20
Last updated
2024-11-21

Condition(s) studied

Chronic Stable Heart Failure

Investigational drug(s) / intervention(s)

Qishenyiqi dripping pillsPlacebo

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Panpan Hao Jinan Shandong
Qianfoshan Hospital, Shandong University Jinan Shandong
Jinan Central Hospital Affiliated to Shandong First Medical University Jinan China

More Qilu Hospital of Shandong University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06699407 on ClinicalTrials.gov ↗ ← All trials in China