NCT05493605

Cardiac Involvement in Wilson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wilson's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-02
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-08-09
• Last updated: 2025-12-17

Locations

1 site across 1 country: France