Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI (FIESTA-MRI)

University Health Network, Toronto

Status: Enrolling

Conditions: Fabry Disease

Treatments: Diagnostic Test: Cardiac MRI, ECG/Holter and Blood Biomarkers

Study type: Interventional

Funder types: Other

Identifiers

NCT04856059

21-5167

Details and patient eligibility

About

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.

Full description

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 rhythm and death. The focus of this study will be on improving the detection of early heart disease before irreversible damage has occurred in order to improve patient outcomes.

It is hypothesized that new cardiac MRI techniques called T1 and T2 mapping will improve the 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 the study will 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fabry disease;
• Age ≥ 18 years.

Exclusion criteria

• History of myocardial infarction;
• Contraindication to MRI.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Cardiac MRI, ECG and Blood Biomarkers

Other group

Description:

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

Treatment:

Diagnostic Test: Cardiac MRI, ECG/Holter and Blood Biomarkers