NCT04440254 Long Duration Holter ECG in Fabry Disease
| NCT ID | NCT04440254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Fabry Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-05-05 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-05-05 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04440254 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Fabry Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04440254 currently recruiting?
Yes, NCT04440254 is actively recruiting participants. Contact the research team at albert.hagege@inserm.fr for enrollment information.
Where is the NCT04440254 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04440254 clinical trial?
NCT04440254 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The trial plans to enroll 40 participants.