About this trial
This study will evaluate whether cardiac MRI T1 and T2 mapping improves our ability to detect early abnormalities in the heart in patients with Fabry disease and identify patients at increase risk of adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fabry disease;
Age ≥ 18 years.
Disqualifiers
History of myocardial infarction;
Contraindication to MRI.
Trial design
Single group
Treatments tested in this trial
Cardiac MRI, ECG/Holter and Blood Biomarkers
Diagnostic testCardiac MRI including T1/T2 mapping, ECG and blood biomarker evaluation will be performed at baseline and follow-up
Treatment groups
Trial outcomes
Primary outcomes
Major Adverse Cardiac Events (MACE)
MACE will be assessed as a composite endpoint defined by the development on one or more of events such as sustained ventricular tachycardia (VT), severe bradycardia, heart failure hospitalization and cardiac death.
Secondary outcomes
The FAbry STabilization indEX (FASTEX) score
FAbry STabilization indEX (FASTEX) score will be evaluated to assess clinical stability or progression of Fabry disease at follow-up. FASTEX score change of ≥20% will be considered an indication of clinical worsening at follow-up. Minimum value 0%. No maximum value. Higher score change indicates worse outcome.
Sponsors and contacts
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University Health Network, Toronto
Lead sponsor
Vancouver General Hospital
Collaborator
The Cleveland Clinic
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
IRCCS Policlinico S. Donato
Collaborator
Alberta Health services
Collaborator
Libin Cardiovascular Institute of Alberta
Collaborator
Vancouver Coastal Health
Collaborator