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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04703751
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of DCM
* Left ventricular ejection fraction (LVEF) ≤ 45% by echocardiography
* Signed informed consent
Exclusion Criteria:
* Less than 3 months from any substantial cardiac therapeutic intervention (such as, e.g. CRT/ICD fitting)
* Less than 3 months from acute coronary syndrome
* BMI lower than 18 or greater than 45kg/m2
* Severe valvular heart disease or left ventricle aneurysm requiring aneurysmectomy or other structural interventions
* Present candidate for heart transplantation
* Active or any history of malignancy or tumor
* Moderate or severe immunodeficiency
* Chronic immunosuppressive therapy
* Acute or chronic infection
* Coagulopathies
* Known alcohol or drug dependence
* Severe renal dysfunction (eGFR\<20mL/min)
* Soft tissue disease or local infection in a place of required artery puncture
* Pregnancy or breastfeeding
* Females of childbearing potential who do not use a highly effective method of contraception, and in absence of a negative highly sensitive urine or serum pregnancy test
* Participation in any other clinical research study that has not reached its primary efficacy endpoint or otherwise would interfere with the patient's participation in this project
* Life expectancy \<12 months
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04703751
Study Brief:
Protocol Section:
NCT04703751