Effect of Agalsidase Alfa on Cardiac Inflammation in Patients With Fabry Disease: A [18F]-FDG PET-CMR Study
Recruiting
Observational Study
Fabry Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 15 – 75
- Sex
- Any
- Study type
- Observational
- Participants needed
- 25 (estimated)
- Sponsor
- Yonsei University · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients aged 15-75 years with Fabry disease confirmed by enzyme assay and gene test
* Patients have not undergone ERT for more than 12 months or patients have not used Agalsidase Alfa in the last 12 months.
* Patients who have cardiac involvement of Fabry disease (end diastol…
Contacts
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