Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04856059

Conditions

Fabry Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac MRI, ECG/Holter and Blood Biomarkers

Study Details

Brief summary:

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.

Conditions

Fabry Disease

Study ID

NCT04856059

Start date

Jun 15, 2021

Status verified date

Apr, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Fabry disease;
  • Age ≥ 18 years.

Exclusion Criteria:

  • History of myocardial infarction;
  • Contraindication to MRI.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Cardiac MRI, ECG and Blood Biomarkers

Additional sequences will be performed during routine clinical cardiac MRI and additional blood samples will be collected during routine blood work.

Interventions

Cardiac MRI, ECG/Holter and Blood Biomarkers

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

Primary outcome measure

  • Major Adverse Cardiac Events (MACE) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Kate Hanneman

416-323-6400kate.hanneman@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Kate Hanneman, MD

416-323-6400Kate.Hanneman@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Fabry disease
  • Fabry cardiomyopathy
  • cardiac MRI
  • CMR
  • T1 mapping
  • T2mapping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-04-16.