A prospective, multicenter, randomized, controlled study to evaluate the clinical outcome of Zhenyuan capsule in the treatment of heart failure after myocardial infarction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200005706

Enrollment

Unknown

Registered

2022-03-14

Start date

2022-05-05

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure after myocardial infarction

Interventions

Control group:Standard therapy+Placebo

Intervention group:Standard therapy+Oral medicine

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Improvement in quality of life as assessed by the KCCQ scale;	—

Secondary

Measure	Time frame
Improvement of NYHA cardiac function;Nt-probnp (or BNP) improves;	—

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital, Fudan University

jbge@zs-hospital.sh.cn021-64041990

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026