NCT07235709 Effect of Agalsidase Alfa on Cardiac Inflammation in Patients With Fabry Disease: A [18F]-FDG PET-CMR Study
| NCT ID | NCT07235709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Fabry Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2025-11-12 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 diastolic maximal wall thickness ≥ 12mm on echocardiography or CMR, decreased native T1 value on CMR, unexplained distinct diastolic dysfunction, unexplained decreased global longitudinal strain on 2D strain echocardiography, or biopsy-proven cardiac involvement) * Patients provided written informed consent to participate in this study * The patient, or patient's legally authorized representative(s), if applicable, understands the nature, scope, and possible consequences of the study and has provided written informed consent that has been approved by the Institutional Review Board/Independent Ethics Committee * The patient must be sufficiently cooperative to participate in this clinical study as judged by the investigator. Exclusion Criteria: * Contraindication for enzyme replacement treatment with Agalsidase Alfa * Patients have previously been treated with Agalsidase Alfa for \> 12 months * Patients unable to undergo PET-CMR due to any condition * Patients who are pregnant * Patients who have active malignancy * Subject who the investigator deems inappropriate to participate in this study
Frequently Asked Questions
Who can join the NCT07235709 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 75 Years, studying Fabry Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07235709 currently recruiting?
Yes, NCT07235709 is actively recruiting participants. Visit ClinicalTrials.gov or contact Yonsei University to inquire about joining.
Where is the NCT07235709 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07235709 clinical trial?
NCT07235709 is sponsored by Yonsei University. The trial plans to enroll 25 participants.