Status:
RECRUITING
Long Duration Holter ECG in Fabry Disease
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Fabry Disease
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The main objective is to assess the occurrence of cardiac arrhythmias and conduction disorders during a three-year follow-up using implantable Holter ECG monitoring in 40 patients with Fabry disease. ...
Detailed Description
The main objective of this non-blinded, monocentric non-randomized study is to assess the occurrence of cardiac arrhythmias and conduction disorders (sinus dysfunction, branch block \[BB\], atrioventr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male patient
- Age greater than or equal to 18 years on the day of inclusion
- Presence of a morbid mutation for MF
- Signature of the informed consent form
- Absence of significant valve disease, verified on medical file (absence stenosis or regurgitation \<2+ in color Doppler on a scale 1 to 4+ by extension of the jet)
- No history of known or documented myocardial infarction nor CAD
- No pacemaker or ICD
- no history of AF, NSVT, high-degree AV block
- Correct echogenicity
- No treatment by corticosteroid or immunosuppressive drugs
- creatinine clearance \>/= 30 Ml/mn
- LVEF ≥ 50% by ultrasound and / or MRI
- No contraindication to MRI (or claustrophobia) and gadolinium injection
- Affiliation to the French social security insurance
Exclusion
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04440254
Start Date
May 5 2021
End Date
April 30 2029
Last Update
January 23 2025
Active Locations (1)
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1
20 Rue Leblanc, HEGP/PARCC, 75015 Paris
Paris, Paris, France, 75015