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RECRUITING Not applicable ClinicalTrials.gov

Cardiac Involvement in Wilson's Disease

Sponsor: Fondation Ophtalmologique Adolphe de Rothschild • ClinicalTrials.gov ID: NCT05493605

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Delivery of a long-term Holter 21 days Or placement of an implantable holter from the outset so syncope (Procedure)
    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.

Eligibility criteria

Inclusion Criteria: * Adult patient with Wilson's disease confirmed by a Leipzig score ≥ 4 * Express consent to participate in the study by the patient or legal guardian in the case of patients under guardianship or by the patient assisted by his curator in the case of patients under guardianship * Member of or beneficiary of a Social Security scheme Exclusion Criteria: * Absolute or relative contraindication to MRI or contrast media * Pregnant, parturient or breast-feeding women: a urine pregnancy test will be carried out in women of childbearing age * Patient with hepatic decompensation (Child-Pugh score stage C) * Patient in neuro-psychiatric decompensation

Conditions

Wilson's Disease

Locations

  • Fondation Adolphe de Rothschild — Paris, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record