Long Duration Holter ECG in Fabry Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2029-04-30

Brief Summary

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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.

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Detailed Description

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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 \[BB\], atrioventricular block \[BAV\], sustained \[TVS\] or non-supported \[TVNS\] ventricular tachycardias, atrial fibrillation \[AF\] during a three-year follow-up in 40 patients with Fabry disease (half with left ventricular hypertrophy) using an implantable Holter ECG device (Medtronic Reveal-LINQ™). The secondary objectives are to analyze the correlations (at 1, 2 and 3 years) of these anomalies with the modifications of :

* cardiac MRI \[Magnetic Resonance Imaging\] data at inclusion \[M0\] and at 36 months \[M36\] (left ventricular hypertrophy \[HVG\], amplitude of the T1 signal, extent of fibrosis); MRIs will be performed before implantation and after removal of the Holter to avoid the reading artifacts linked to the device.
* echocardiographic measurements of the left ventricle (overall longitudinal strain systolic \[SGL\] and ejection fraction \[FE\])
* biological parameters (BNP or NT-proBNP, ultra-sensitive troponin and Lyso-Gb3)
* the overall severity of the disease assessed by MSSI (Mainz Severity Score Index), DFG and proteinuria

Conditions

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Fabry Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ONE

One single group of patients

Group Type OTHER

Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device

Intervention Type DIAGNOSTIC_TEST

Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region

Interventions

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Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device

Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No