Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT06478732
Eligibility Criteria:
Inclusion Criteria:
1. Be of either sex with age ≥ 18 years and ≤ 75 years.
2. Hospitalization due to AMI (onset to randomization ≤ 2 weeks), including STEMI and NSTEMI.
3. Meeting the diagnostic criteria for chronic HF, including:
(1) Symptoms and/or signs of heart failure; (2) LVEF (Simpson's method) \< 50%, and NT-proBNP ≥ 125pg/mL before enrollment. 4. Patients must be willing to comply with the study protocol and give the informed consent.
Exclusion Criteria:
1. Contraindications to cardiopulmonary exercise testing (bicycle ergometer) or 6-minute walking test.
2. Pregnancy, breastfeeding, or planning pregnacy within 1 year.
3. Patients who have undergone mechanical circulatory support (including intra-aortic balloon pump, Impella, ECMO, etc.) or endotracheal intubation.
4. History of viral cardiomytis or non-ischemic cardiomyopathy including dilated cardiomyopathy, hypertrophic cardiomyopathy, perinatal cardiomyopathy, etc.
5. Moderate to severe valvular heart disease or a history of valve replacement.
6. Severe liver dysfunction \[ALT ≥ 3 times the upper limit of normal range or renal dysfunction (eGFR\<60 mL /min/1.73m2)\].
7. Malignant tumors or other diseases, with expected life expectancy \<1 year.
8. Inability to use smartphones or communicate with the management team for any reason.
9. Enrolled in other clinical trials.
10. Any other clinical conditions unsuitable for this study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06478732
Study Brief:
Protocol Section:
NCT06478732