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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device
Diagnostic test
Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: ONEOther 1 intervention

Trial outcomes

Primary outcomes

Occurrence of cardiac arrhythmias and conduction disorders

Time frame

3 years

Secondary outcomes

Correlations between electrical disorders and changes in MRI/ultrasonic data (LV mass, T1 signal, fibrosis extent , systolic strain, ejection fraction), concentrations of BNP, troponin, Lyso-Gb3, MSSI score and renal function

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut National de la Santé Et de la Recherche Médicale, France

Lead sponsor

Source ClinicalTrials.gov

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