Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT04440254

Long Duration Holter ECG in Fabry Disease

Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-02-18

40

Participants Needed

1

Research Sites

416 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Long Duration Holter ECG in Fabry Disease

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (no stenosis or regurgitation less than 2+ on color Doppler scale 1 to 4+)
  • No history of known or documented myocardial infarction or coronary artery disease
  • No pacemaker or implantable cardioverter defibrillator (ICD)
  • No history of atrial fibrillation, non-sustained ventricular tachycardia, or high-degree atrioventricular block
  • Correct echogenicity
  • No treatment by corticosteroid or immunosuppressive drugs
  • Creatinine clearance greater than or equal to 30 mL/min
  • Left ventricular ejection fraction (LVEF) 50% or higher by ultrasound and/or MRI
  • No contraindication to MRI or gadolinium injection (no claustrophobia)
  • Affiliation to the French social security insurance
Not Eligible

You will not qualify if you...

  • Female patient
  • Age below 18 years
  • Presence of significant valve disease (stenosis or regurgitation 2+ or higher)
  • History of myocardial infarction or coronary artery disease
  • Presence of pacemaker or ICD
  • History of atrial fibrillation, non-sustained ventricular tachycardia, or high-degree atrioventricular block
  • Poor echogenicity
  • Treatment with corticosteroid or immunosuppressive drugs
  • Creatinine clearance below 30 mL/min
  • Left ventricular ejection fraction below 50%
  • Contraindication to MRI or gadolinium injection including claustrophobia
  • No affiliation to the French social security insurance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

20 Rue Leblanc, HEGP/PARCC, 75015 Paris

Paris, Paris, France, 75015

Actively Recruiting

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Research Team

A

Albert HAGEGE, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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