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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04325594
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 years and older
* Registered at the Research-Clinical Center for Cardiac Surgery and Transplantology
* Established diagnosis of non-ischemic dilated cardiomyopathy (NYHA Class III-IV)
* Non-ischemic etiology confirmed by coronary angiography or contrast-enhanced cardiac CT
* Left ventricular ejection fraction (LVEF) ≤ 35% based on echocardiography or cardiac CT
* Clinical indications for implantation of an implantable cardioverter-defibrillator (ICD), regardless of actual implantation status
* No clinical or laboratory signs of dysfunction or insufficiency of other major organs
* No history of malignancy within the past 5 years and no abnormal tumor markers
* Signed written informed consent
Exclusion Criteria:
* Ischemic heart disease or prior cardiac surgery, including coronary artery stenting
* Significant valvular heart disease, intracardiac thrombus, left ventricular aneurysm, hypertrophic, postpartum, alcoholic or restrictive cardiomyopathy, congenital heart defects, or resistant hypertension
* Stroke within the past 2 years
* Autoimmune or immunodeficiency disorders
* Polyvalent allergy
* Decompensated chronic comorbidities
* Use of systemic corticosteroids, cytotoxic or immunosuppressive drugs (e.g., cyclophosphamide, methotrexate, cyclosporine, azathioprine) within 4 weeks before enrollment
* Positive tests for hepatitis B or C, syphilis, or HIV/AIDS
* Active systemic infections requiring targeted antibiotic therapy
* Untreated peptic ulcer disease or history of gastrointestinal bleeding
* Clinically significant traumatic brain injury requiring treatment
* Uncontrolled epileptic seizures
* Porphyria
* Requirement for hospice-level care
* Alcohol or drug abuse, lack of permanent residence, severe depression, disorientation, or inability to participate in follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04325594
Study Brief:
Protocol Section:
NCT04325594