Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI

ConditionFabry Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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 volunteers

Qualifiers

Fabry disease;

Age ≥ 18 years.

Disqualifiers

History of myocardial infarction;

Contraindication to MRI.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cardiac MRI, ECG/Holter and Blood Biomarkers

    Diagnostic test

    Cardiac MRI including T1/T2 mapping, ECG and blood biomarker evaluation will be performed at baseline and follow-up

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Cardiac MRI, ECG and Blood BiomarkersOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

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.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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