Long Duration Holter ECG in Fabry Disease

Launched by INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE, FRANCE · Jun 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying patients with Fabry disease, a condition that can affect the heart, among other organs. The main goal is to monitor heart rhythms and any heart conduction issues over three years using a special device called an implantable Holter ECG. This device will help doctors see how often these heart problems occur in 40 male patients. Additionally, the study will look at how these heart issues relate to changes seen in heart imaging tests and the overall severity of Fabry disease.

To participate in this trial, you need to be a male, at least 18 years old, and have a specific genetic mutation related to Fabry disease. You should not have major heart valve problems, a history of heart attacks, or certain types of heart rhythm issues. If you qualify, you can expect to have regular heart monitoring and imaging tests over the three years, helping researchers understand more about how Fabry disease affects the heart. It's also important to know that you need to be part of the French social security insurance system to join this study.

Gender

MALE

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