ITMCTR2200005706
Not yet recruiting
Phase 4
A prospective, multicenter, randomized, controlled study to evaluate the clinical outcome of Zhenyuan capsule in the treatment of heart failure after myocardial infarction
Zhongshan Hospital affiliated to Fudan University0 sitesTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Heart failure after myocardial infarction
- Sponsor
- Zhongshan Hospital affiliated to Fudan University
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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.
Outcomes
Primary Outcomes
Not specified
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