Actively Recruiting
Effect of Agalsidase Alfa on Cardiac Inflammation in Patients With Fabry Disease: A [18F]-FDG PET-CMR Study
Led by Yonsei University · Updated on 2025-12-01
25
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Agalsidase Alfa on Cardiac Inflammation in Patients With Fabry Disease: A [18F]-FDG PET-CMR Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 15 to 75 years with Fabry disease confirmed by enzyme assay and gene test
- Patients not treated with enzyme replacement therapy for more than 12 months or not using Agalsidase Alfa in the last 12 months
- Patients with cardiac involvement of Fabry disease confirmed by specific heart measurements or biopsy
- Patients who have provided written informed consent
- Patients able and cooperative to participate as judged by the investigator
You will not qualify if you...
- Contraindication to enzyme replacement treatment with Agalsidase Alfa
- Patients previously treated with Agalsidase Alfa for more than 12 months
- Patients unable to undergo PET-CMR scanning
- Pregnant patients
- Patients with active cancer
- Patients deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here