Status:
UNKNOWN
Impact of Agalsidase Alfa Therapy on Cardiac funcTION in Patients With Fabry's Cardiomyopathy
Lead Sponsor:
Yonsei University
Conditions:
Fabry Disease
Eligibility:
All Genders
16-75 years
Brief Summary
Study Design: This is an observational study. No treatment or intervention will be assigned to the subjects. All patients will receive full standard of care concomitant medication for the treatment of...
Detailed Description
1. Objectives - The purpose of this study is to evaluate the impact of ERT with Agalsidase Alfa on LV diastolic function and flow in patients with Fabry's cardiomyopathy using LV 2D strain, diastolic ...
Eligibility Criteria
Inclusion
- Patients aged 16\~ 75 years with Fabry disease confirmed by enzyme assay and gene test
- Patients who have LVH in 2D echocardiography (end diastolic septum and posterior wall thickness ≥ 12mm) or Patients who present with cardiac changes (indicative of disease progression such as decreased global longitudinal strain on 2D strain echocardiography or low native T1 mapping on CMR)
- Patients provided written informed consent to participate in this study
Exclusion
- Contraindication for enzyme replacement treatment with Agalsidase Alfa
- Patients who cannot receive supine bicycle stress echocardiography, contrast echocardiography or CMR
- Patients with hemodynamically significant valvular heart disease or arrhythmias
- Patients who have history of acute myocardial infarction or congestive heart failure with reduced LV ejection fraction of less than 35%
- Patients who had any cerebrovascular accident in the prior 6 months
- Scheduled or planned surgery in the next 6 months
- Patients with chronic liver cirrhosis
- Patients who are allergic to contrast agent (e.g. Definity�, Lantheus Medical Imaging, North Billerica, MA, USA)
Key Trial Info
Start Date :
July 12 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03230591
Start Date
July 12 2017
End Date
January 1 2025
Last Update
June 24 2021
Active Locations (1)
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1
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722