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Clinical Trials in France / NCT04440254
Recruiting Not applicable

Long Duration Holter ECG in Fabry Disease

NCT04440254 · tracked via the Priya Life Science France tracker
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Phase
Not applicable
Started
2021-05-05
Last updated
2026-02-18

Condition(s) studied

Fabry Disease

Investigational drug(s) / intervention(s)

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

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

Study 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. 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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Occurrence of cardiac arrhythmias and conduction disorders — 3 years

Trial sites (1)

FacilityCityRegionStatus
20 Rue Leblanc, HEGP/PARCC, 75015 Paris Paris Paris Recruiting

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Other trials for the same condition

Fabry Disease Registry & Pregnancy Sub-registry Recruiting
A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease Active, not recruiting
Study of the Quality of Life of Patients With Fabry Disease Aged 65 and Over With and Without Specific Treatment Recruiting
Care Pathway for Patients With Fabry's Disease (Fabry-PATH) Starting soon
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04440254 on ClinicalTrials.gov ↗ ← All trials in France