Biomarkers and Cardiac Imaging Diagnostic Assay for Monitoring Patients With Fabry Disease

Plain-language summary

This study evaluates the use of biomarkers and cardiac imaging tests for monitoring people with Fabry disease, with some patients receiving Agalsidase beta enzyme therapy. It enrolls people aged 18 and older who have been diagnosed with Fabry disease and have certain cardiac findings. It is a trial without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Mackay Memorial Hospital

Intervention

Agalsidase beta

Start date

9/19/2023

Estimated completion

9/30/2027

Countries

Taiwan

Related genes

Locations

• Taipei, Taiwan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 18 years or older
* Male or female with Fabry disease diagnosed
* Presence of any one of following abnormal criteria of either: 1) Cardio-specific Biomarker; 2) Abnormal elevated value of plasma Gb3 or Lyso-Gb3; 3) Electrocardiography (ECG); 4) Cardio-specific Image.
* Group A: ERT Treatment naïve Fabry patients
* Group B: Agalsidase beta (ERT) exposed or treated Fabry patients
* Willing and able to comply with the required clinic visits, study procedures and assessments

Exclusion Criteria:

* Patient who are unwilling to sign inform consent form