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Functional Capacity in Anderson-Fabry Disease Patients

Recruitingn/aAges any - anyAllIRCCS Policlinico S. Donato
NCT06884358 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 patients with a genetic diagnosis of Anderson-Fabry Disease. Participants will undergo: * baseline evaluation: clinical evaluation, disease staging with FASTEX and MSSI, KCCQ for quality of life assessment, resting 12-leads ECG, 6MWT, CPET-ESE and contrast-enhanced CMR; * before 36 months from baseline: resting 12-leads ECG, 2D rest and stress echocardiogram, CPET-ESE, contrast-enhanced CMR, disease staging with FASTEX and MSSI and KCCQ for quality of life assessment; * up to 7 years from baseline: clinical follow-up.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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of AFD, according to current guidelines; * Informed written consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care (for patients age \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 Criteria: * 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.
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What it tests

  • Not listed
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Where

5 sites
Spedali Civili Hospital
Brescia, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Regina Margherita Hospital
Turin, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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