Cardiac Involvement in Wilson's Disease

Last updated: June 3, 2024
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Overall Status: Active - Recruiting

Phase

N/A

Condition

Wilson's Disease

Liver Disease

Liver Disorders

Treatment

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

Clinical Study ID

NCT05493605
APS_2021_9
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thecase of patients under guardianship or by the patient assisted by his curator in thecase of patients under guardianship

  • Member of or beneficiary of a Social Security scheme

Exclusion

Exclusion Criteria:

  • Absolute or relative contraindication to MRI or contrast media

  • Pregnant, parturient or breast-feeding women: a urine pregnancy test will be carriedout in women of childbearing age

  • Patient with hepatic decompensation (Child-Pugh score stage C)

  • Patient in neuro-psychiatric decompensation

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Delivery of a long-term Holter 21 days Or placement of an implantable holter from the outset so syncope
Phase:
Study Start date:
March 02, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Fondation Adolphe de Rothschild

    Paris, 75019
    France

    Active - Recruiting

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