Status:

COMPLETED

Anderson Fabry Disease - the Power of Information.

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Fabry Disease

Eligibility:

All Genders

Up to 72 years

Phase:

NA

Brief Summary

The goal of this before-after control-impact study is to determine whether providing targeted information on Fabry disease (FD) to cardiologists and tutoring them in the evaluation of patients with un...

Detailed Description

Background: In Fabry disease (FD), cardiac involvement is frequent and has strong prognostic implications. The main expression of Fabry cardiomyopathy (FC) is left ventricular hypertrophy, mimicking s...

Eligibility Criteria

Inclusion

  • Patients with hypertrophic cardiomyopathy and features suggestive of possible Anderson-Fabry disease, defined as one of the following:
  • Patients with left ventricular hypertrophy (LVH) of unknown aetiology (diagnosed in/after the 3rd decade of life) defined by a wall thickness≥13 mm measured on echocardiography or cardiac magnetic resonance, in absence of male-to-male transmission and co-existent pathologies that could explain the increased LV wall thickness (i.e. hypertension, aortic stenosis);
  • Patients with LVH (diagnosed in/after the 3rd decade of life) and ECG findings frequently encountered in Fabry cardiomyopathy (short PR interval with high QRS voltage, remarkable repolarization abnormalities..);
  • Patients with unexplained LVH (diagnosed in/after the 3rd decade of life) and previous history of stroke, renal failure or clinical characteristics compatible with FD multiorgan involvement.

Exclusion

  • NA

Key Trial Info

Start Date :

November 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 6 2024

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT07136662

Start Date

November 14 2022

End Date

June 6 2024

Last Update

August 22 2025

Active Locations (1)

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1

Fondazione Policlinico Gemelli IRCCS

Roma, RM, Italy, 00168