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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04440254
Other study ID # C19-57
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2025

Study information

Verified date May 2020
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The main objective of this non-blinded, monocentric non-randomized study is to assess the occurrence of cardiac arrhythmias and conduction disorders (sinus dysfunction, branch block [BB], atrioventricular block [BAV], sustained [TVS] or non-supported [TVNS] ventricular tachycardias, atrial fibrillation [AF] during a three-year follow-up in 40 patients with Fabry disease (half with left ventricular hypertrophy) using an implantable Holter ECG device (Medtronic Reveal-LINQ™). The secondary objectives are to analyze the correlations (at 1, 2 and 3 years) of these anomalies with the modifications of :

- cardiac MRI [Magnetic Resonance Imaging] data at inclusion [M0] and at 36 months [M36] (left ventricular hypertrophy [HVG], amplitude of the T1 signal, extent of fibrosis); MRIs will be performed before implantation and after removal of the Holter to avoid the reading artifacts linked to the device.

- echocardiographic measurements of the left ventricle (overall longitudinal strain systolic [SGL] and ejection fraction [FE])

- biological parameters (BNP or NT-proBNP, ultra-sensitive troponin and Lyso-Gb3)

- the overall severity of the disease assessed by MSSI (Mainz Severity Score Index), DFG and proteinuria


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device
Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of cardiac arrhythmias and conduction disorders 3 years
Secondary Correlations between electrical disorders and changes in MRI/ultrasonic data (LV mass, T1 signal, fibrosis extent , systolic strain, ejection fraction), concentrations of BNP, troponin, Lyso-Gb3, MSSI score and renal function 3 years
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