Actively Recruiting
Functional Capacity in Anderson-Fabry Disease Patients
Led by IRCCS Policlinico S. Donato · Updated on 2025-03-19
100
Participants Needed
5
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Functional Capacity in Anderson-Fabry Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a genetic diagnosis of Anderson-Fabry Disease according to current guidelines
- Written informed consent provided (for patients under 18, caregiver consent is required)
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min and other contraindications for cardiac magnetic resonance imaging (CMR)
- Musculoskeletal limitations preventing exercise testing on a cycle ergometer
- Pregnant or breastfeeding women
- Any serious medical or psychiatric illness that could interfere with understanding the consent form according to investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Spedali Civili Hospital
Brescia, Brescia, Italy, 25123
Active, Not Recruiting
2
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milan, Italy, 20122
Active, Not Recruiting
3
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy, 20097
Actively Recruiting
4
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza, Italy, 20900
Active, Not Recruiting
5
Regina Margherita Hospital
Turin, Turin, Italy, 10124
Active, Not Recruiting
Research Team
M
Massimo Piepoli, MD, PhD
CONTACT
G
Gianluigi Guida, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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