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RECRUITING
NCT05493605
NA

Cardiac Involvement in Wilson's Disease

Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

View on ClinicalTrials.gov

Summary

Heart damage by copper accumulation has been reported in Wilson's Disease. However, the disease epidemiology is still poorly understood. A number of studies on pediatric populations have not shown any significant cardiac involvement apart from early dysautonomia. This could suggest that the clinical manifestations related to the copper accumulation in the heart appears with the duration of the disease. Case-control studies on adult populations have highlighted various electrocardiographic (ECG) abnormalities more frequent in patients with Wilson's Disease than in healthy volunteers, but all these studies involved small number of patients (maximum 60). The hypothesis is that there is cardiac involvement in Wilson's Disease, requiring screening, follow-up and appropriate support.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-03-02

Completion Date

2026-03

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

PROCEDURE

Delivery of a long-term Holter 21 days Or placement of an implantable holter from the outset so syncope

The intervention consists of setting up a morphological and rhythmological cardiological follow-up of patients with confirmed Wilson's disease. It will require the wearing of a long-term Holter (21 days) and for some patients the installation of an implantable cardiac monitor.

Locations (1)

Fondation Adolphe de Rothschild

Paris, France