NCT04440254Recruiting
Long Duration Holter ECG in Fabry Disease
Natural History of Cardiac Rhythm and Conduction Disorders in Patients With Fabry Disease Evaluated by Long-Term Implantable Holter ECG
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 12 Jun 2020
- Start date
- 5 May 2021
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Fabry disease
- NCT number
- NCT04440254
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 5 May 2021 to the primary completion date, 30 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 20 Rue Leblanc, HEGP/PARCC, 75015 Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.