NCT06699407Not yet recruitingPhase 4
Qishenyiqi for Ventricular Remodeling After Myocardial Infarction
Efficacy and Safety of Qishenyiqi Dripping Pills in Patients With Ventricular Remodeling and Chronic Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 21 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 18 Nov 2024
- Start date
- 20 Nov 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Heart failure
- NCT number
- NCT06699407
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 210
- From 20 Nov 2024 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 5\) Patients who participated in clinical research of other drugs within 3 months before being selected;
Other illness
- 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;
Other
- 4\) Pregnant or nursing, or having the intention to give birth within one year;
- 6\) Patients with poor sound transmission windows are examined by transthoracic ultrasound.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qianfoshan Hospital, Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Panpan Hao Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jinan Central Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.