Status:

ACTIVE_NOT_RECRUITING

Role of Cardiovascular Imaging in the Early Diagnosis of Hypertrophic Cardiomyopathy in Women

Lead Sponsor:

IRCCS San Raffaele

Collaborating Sponsors:

Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy

Conditions:

Hypertrophic Cardiomyopathy (HCM)

Eligibility:

All Genders

Brief Summary

Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disorder worldwide with a prevalence of 1:500 in the general population. It is mainly associated to mutations in genes encoding car...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2030

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06882668

Start Date

March 1 2025

End Date

March 1 2030

Last Update

March 18 2025

Active Locations (1)

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1

Vita Salute San Raffaele Hospital

Milan, Italy, 20054