Monitoring heart rhythms in patients with Fabry disease
Official title: Natural History of Cardiac Rhythm and Conduction Disorders in Patients With Fabry Disease Evaluated by Long-Term Implantable Holter ECG
Run by Institut National de la Santé Et de la Recherche Médicale, France · NCT04440254 · Data updated 2026-11-12
This study is testing how heart rhythms change over three years in people with Fabry disease using a special heart monitor to see how it relates to their overall heart health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 40 (estimated) |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Paris, Paris) |
| Status | Recruiting |
| Started | May 5, 2021 |
| Main results expected | April 30, 2029 |
| Study ends | April 30, 2029 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT04440254 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are male patients aged 18 and older with a confirmed morbid mutation for Fabry disease and no significant heart conditions.
✕Probably not a fit
Patients with a history of myocardial infarction, significant valve disease, or those currently on corticosteroids or immunosuppressive drugs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to monitor cardiac arrhythmias and conduction disorders in patients with Fabry disease over a three-year period using an implantable Holter ECG device. It will involve 40 patients, half of whom have left ventricular hypertrophy, and will assess the relationship between these cardiac anomalies and changes in cardiac MRI, echocardiographic parameters, and overall disease severity. The study is non-blinded and non-randomized, focusing on the long-term effects of Fabry disease on heart health.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of cardiac complications in patients with Fabry disease.
How similar studies have gone: While there have been studies on cardiac monitoring in other conditions, this specific approach in Fabry disease is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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20 Rue Leblanc, HEGP/PARCC, 75015 Paris
Paris, Paris, France Recruiting
Study contacts
- Study coordinator: Albert HAGEGE, Dr
- Email: albert.hagege@inserm.fr
- Phone: 0156093713
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.