Effect of Agalsidase Alfa on Cardiac Inflammation in Patients With Fabry Disease: A [18F]-FDG PET-CMR Study

Sponsor
Yonsei University
Study ID
NCT07235709
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

This is a prospective observational study. All patients will initiate and maintain treatment with agalsidase alfa during the study period. All patients will receive a full standard of care concomitant medication for the treatment of their cardiac condition. Twenty-five patients with genetically confirmed Anderson-Fabry disease will undergo PET-CMR at baseline and after 12 months of treatment with Agalsidase Alfa for follow-up.

Key Dates

Start date
Nov 12, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: Fabry's disease
    atients aged 15-75 years with Fabry disease confirmed by enzyme assay and gene test

Primary Outcome Measure

To evaluate the impact of ERT with Agalsidase Alfa on change of myocardial inflammation in patients with Fabry's cardiomyopathy using PET-CMR. [ Time Frame: 1 year ]

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