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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT06882668
Eligibility Criteria:
Inclusion Criteria:
* Able to sign informed consent.
* First-degree relatives of HCM patients already in follow-up at the participating centres, independently from the genetic status of the affected family member.
* Unselected subjects referred to the Cardiomyopathy Outpatient Clinics with clinical suspicion of HCM.
* Availability to perform transthoracic echocardiographic imaging, and to perform CMR.
Exclusion Criteria:
* Known history of systemic hypertension with documented secondary LV heart disease.
* Known grown up congenital heart disease patients with documented secondary LV hypertrophy.
* Known hemodynamically relevant valvular diseases with documented secondary LV hypertrophy.
* Known HCM phenocopies: infiltrative diseases mimicking HCM (cardiac amyloidosis, haemochromatosis and secondary hemosiderosis), metabolic storage diseases (Anderson-Fabry disease, Pompe disease, Danon disease, PRKAG2-related disease).
* Neuromuscular diseases as Friedreich ataxia, distrophinopathies and desminopathies.
* Known mitochondrial diseases with documented myocardial involvement.
* Known malformation syndromes as RAS/MAPK disorders (Noonan syndrome, LEOPARD syndrome, Costello syndrome), cardiofaciocutaneous syndrome.
* Previous long-term treatment with tacrolimus, hydroxychloroquine, steroids.
* Known absolute contraindications to CMR.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT06882668
Study Brief:
Protocol Section:
NCT06882668