FIESTA- Cardiac MRI Study

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

Sponsors

Lead Sponsor: University Health Network, Toronto

Source University Health Network, Toronto
Brief Summary

Fabry disease is an inherited disorder that affects many organs in the body, including the heart. Men and women are both affected, with average life expectancy reduced by 10-20 years. The heart muscle can become thick and scarred in over half of patients, eventually resulting in heart failure, abnormal heart rhythm and death. We are focused on improving the detection of early heart disease before irreversible damage has occurred in order to improve patient outcomes. The techniques that have traditionally been used to look for disease in the heart are inadequate, as they often identify abnormalities once permanent scarring has already developed. Patients with heart damage have poor outcomes even with treatment. Therefore, it is critical to develop an earlier and reliable way to identify subtle disease in the heart, so that treatment can be initiated early when patients will benefit the most. We have previously shown that cardiac magnetic resonance imaging (MRI) can identify changes in the heart muscle in patients with Fabry disease. We hypothesize that new cardiac MRI techniques called T1 and T2 mapping will improve our ability to detect early abnormalities in the heart. Early detection of cardiac disease may enable a personalized treatment approach, potentially improving patient outcomes. The results of this study will help identify which patients might benefit from early initiation of treatment to prevent bad outcomes in the future by using cardiac MRI to identify those at higher risk.

Overall Status Not yet recruiting
Start Date 2021-05-17
Completion Date 2026-12-31
Primary Completion Date 2022-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Major adverse cardiac events (MACE) 36 months
Enrollment 100
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: cardiac MRI

Description: additional sequences performed during routine cardiac MRI

Arm Group Label: cardiac MRI scan

Eligibility

Criteria:

Inclusion Criteria: - Fabry disease; - Age >= 18 years. Exclusion Criteria: - History of myocardial infarction; - Contraindication to MRI.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Kate Hanneman, MD Principal Investigator University Health Network, Toronto
Overall Contact

Last Name: Kate Hanneman, MD

Phone: 416-323-6400

Phone Ext.: 5621

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: cardiac MRI scan

Type: Other

Description: additional sequences are performed during routine clinical cardiac MRI

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: cardiac MRI

Primary Purpose: Diagnostic

Masking: None (Open Label)

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