Status:
ACTIVE_NOT_RECRUITING
Arrhythmia Burden, Risk of Sudden Cardiac Death and Stroke in Patients With Fabry Disease
Lead Sponsor:
University Hospital Birmingham NHS Foundation Trust
Collaborating Sponsors:
Royal Free Hospital NHS Foundation Trust
Northern Care Alliance NHS Foundation Trust
Conditions:
Fabry Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fabry disease (FD) is a genetic disorder that leads to progressive accumulation of fat or 'sphingolipid' within the tissues, including the heart muscle and conductive tissue. Improvements in the detec...
Detailed Description
This is a 3-year open-label multicentre randomised controlled trial assessing arrhythmia burden in patients with Fabry cardiac disease. This is an observational study, but with implantable loop record...
Eligibility Criteria
Inclusion
- Patients with genotypically or enzymatically confirmed FD
- Adults \> 18 years of age
- Evidence of cardiac involvement from FD involving either:
- Any ECG abnormality associated with FD
- Low T1 on CMR (below centre-specific normal range according to sex)
- LVH on transthoracic echo (defined as MWT \>12mm)
Exclusion
- Patient with an existing cardiac device (PPM, ICD or ILR).
- Known dual pathology:
- Known coronary artery disease (positive non-invasive imaging, confirmed myocardial infarction, percutaneous or surgical revascularisation). Patients \>40 years old with symptoms that could be from coronary artery disease will have this excluded
- Known cardiomyopathy disease causing mutation (e.g. SCN5, MYBPC3)
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT03305250
Start Date
September 18 2019
End Date
July 1 2027
Last Update
May 14 2025
Active Locations (7)
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1
University of Sydney
Sydney, Australia
2
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TH
3
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
4
Cardiff and Vale University Health Board
Cardiff, United Kingdom