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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT04992832
Eligibility Criteria:
Inclusion Criteria:
1. LVEF≤40％;
2. NYHA II-IV;
3. Received maximally tolerated guideline-directed medical therapy ( GDMT) for at least 3 months before enrollment;
4. Angiography or coronary CT within 6 months shows that there is no indication for PCI / CABG; Or PCI / CABG indications, but refused.
Exclusion Criteria:
1. Severe valvular heart disease, congenital heart disease, acute viral myocarditis and acute coronary syndrome.
2. PCI / CABG, ICD / permanent pacemaker / CRT implantation within 3 months.
3. Recent cerebrovascular disease (\<6 months).
4. eGFR\<30ml/min, or ALT/AST\>120U/L.
5. Hematologic disease: anemia (hemoglobin ≤9.0 g/dL); leukopenia (\<3500/μL); thrombocytopenia (\<70000/μL); myeloproliferative disorders, myelodysplastic syndrome, acute or chronic leukemia, and plasma cell dyscrasias (multiple myeloma, amyloidosis) .
6. Malignant tumor within 5 years.
7. Life expectancy \<1 year according any disease.
8. Uncontrolled acute infectious diseases.
9. Known or suspected of being sensitive to the study drugs or its ingredients.
10. Not suitable for inclusion according to the evaluation of the sponsors or unwilling to comply with the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04992832
Study Brief:
Protocol Section:
NCT04992832