Status:

RECRUITING

Functional Capacity in Anderson-Fabry Disease Patients

Lead Sponsor:

IRCCS Policlinico S. Donato

Conditions:

Anderson-Fabry Disease

Eligibility:

All Genders

Brief Summary

The goal of this observational study is to observe the relation between excercise parameters - assessed by CPET - and rest/stress hemodynamic parameters - assessed by echocardiogram and CMR - in patie...

Eligibility Criteria

Inclusion

  • Patients with a genetic diagnosis of AFD, according to current guidelines;
  • Informed written consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care (for patients age \<18 years old, written consent from a caregiver is mandatory).

Exclusion

  • eGFR \<30 ml/min and other contraindications for CMR (relative controindication: patients with implantable device);
  • Musculoskeletal limitation for exercise test on the cyclo ergometer;
  • Pregnant or breastfeeding women;
  • Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a full comprehension of the written consent form.

Key Trial Info

Start Date :

November 13 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2032

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06884358

Start Date

November 13 2024

End Date

January 1 2032

Last Update

March 19 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Spedali Civili Hospital

Brescia, Brescia, Italy, 25123

2

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milan, Italy, 20122

3

IRCCS Policlinico San Donato

San Donato Milanese, Milan, Italy, 20097

4

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza, Italy, 20900