Chronic Stable Heart Failure
Conditions
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.
Interventions
DRUGQishenyiqi dripping pills
Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months
DRUGPlacebo
Placebo, 1 bag once, three times a day, 12 months
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LVEDVI=LVEDV/BSA | From baseline to 12 months after follow-up | Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months |
Countries
China
Contacts
Primary ContactPanpan Hao
Outcome results
None listed