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Cardiac Involvement in Wilson's Disease

RecruitingNAAges 18 Years - anyAllFondation Ophtalmologique Adolphe de Rothschild
NCT05493605 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Fondation Adolphe de Rothschild
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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