Long Duration Holter ECG in Fabry Disease
ConditionFabry Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
About this trial
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. The secondary objectives are to analyze the correlations of these anomalies with changes in cardiac MRI and echocardiographic parameters as biological parameters and overall severity of the disease assessed by MSSI.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov