Qishenyiqi for Ventricular Remodeling After Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Qishenyiqi dripping pills, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Stable Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Qishenyiqi Dripping Pills in Patients With Ventricular Remodeling and Chronic Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
Overview
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.
Interventions
- Drug Qishenyiqi dripping pills
Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months - Drug Placebo
Placebo, 1 bag once, three times a day, 12 months
Primary outcome measures
- LVEDVI=LVEDV/BSA [Time frame: From baseline to 12 months after follow-up]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Panpan Hao — Jinan
- Qianfoshan Hospital, Shandong University — Jinan
- Jinan Central Hospital Affiliated to Shandong First Medical University — Jinan
Identifiers
NCT: NCT06699407 · Qishenyiqi and HFrEF