A prospective, multicenter, randomized, controlled study to evaluate the clinical outcome of Zhenyuan capsule in the treatment of heart failure after myocardial infarctio
- Conditions
- Heart failure after myocardial infarction
- Registration Number
- ITMCTR2200005706
- Lead Sponsor
- Zhongshan Hospital affiliated to Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) 18 years old = age = 85 years old.
(2) The admission diagnosis is consistent with acute myocardial infarction within 28 days (within 28 days of onset).
(3) Heart failure occurs after this myocardial infarction, and the diagnostic criteria for heart failure include:
a) Symptoms and/or signs of heart failure, and Killip class II-IV or NYHA class II-IV;
b) NT-proBNP = 300 pg/ml (= 600 pg/ml in patients with atrial fibrillation), or BNP = 100 pg/ml (= 200 pg/ml in patients with atrial fibrillation) detected at any time after admission.
(4) The patients are willing to follow the research protocol and sign the informed consent.
(1) Pregnant women or patients planning to become pregnant within 1 year.
(2) Patients receiving intra-aortic balloon counterpulsation and endotracheal intubation.
(3) History of dilated cardiomyopathy, perinatal cardiomyopathy, chemotherapy-induced cardiomyopathy, hereditary hypertrophic cardiomyopathy, invasive cardiomyopathy, and viral myocarditis.
(4) Have a history of moderate or above valvular disease.
(5) Severe abnormal liver function (ALT or AST exceeding 3 times the upper limit of the normal range (ULN), or total bilirubin>1.5mg/dl), abnormal renal function (eGFR<30ml/min/1.73) due to non-cardiac causes m2).
(6) Patients with malignant tumors.
(7) History of drug or alcohol abuse within the past 12 months.
(8) Participate in other clinical studies within 1 month before enrollment.
Study & Design
- Study Type
- Treatment study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in quality of life as assessed by the KCCQ scale;
- Secondary Outcome Measures
Name Time Method Improvement of NYHA cardiac function;Nt-probnp (or BNP) improves;