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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT03572569
Eligibility Criteria:
Inclusion Criteria:
1. Index patients:
* Age ≤18 years
* written informed consent of parents/legal guardians
* diagnosis of primary cardiomypathy:
* DCM: left ventricular (LV) systolic dysfunction and dilatation greater than two standard deviations (SD) above the mean of a normal population
* HCM: LV hypertrophy and septal wall thickness above two SD
* RCM: diastolic dysfunction and concordant atrial enlargement
* LVNC: separation of the myocardium into a compacted (C) and a non- compacted (NC) layer with an NC/C ratio \>2 in echocardiography and/or \>2.3 in CMR
* ARVC: according to the revised Task Force Criteria
2. First-degree family members (parents and siblings):
* Age ≥3 years
* written informed consent of parents/legal guardians and siblings ≥18 years
Exclusion Criteria:
* unwillingness to give consent
* myocardial inflammation / myocarditis
* systemic disease with cardiac involvement (secondary cardiomyopathy)
* structural congenital heart disease
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03572569
Study Brief:
Protocol Section:
NCT03572569