Monitoring heart rhythms in patients with Fabry disease
Natural History of Cardiac Rhythm and Conduction Disorders in Patients With Fabry Disease Evaluated by Long-Term Implantable Holter ECG
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Paris, Paris) |
| Trial ID | NCT04440254 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18 and older with a confirmed morbid mutation for Fabry disease and no significant heart conditions.
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.
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 performed: While there have been studies on cardiac monitoring in other conditions, this specific approach in Fabry disease is relatively novel and untested.
Eligibility criteria
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 this trial is running
Paris, Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.