Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05493605

Cardiac Involvement in Wilson's Disease

Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-12-17

150

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Cardiac Involvement in Wilson's Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondation Adolphe de Rothschild

Paris, France, 75019

Actively Recruiting

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Research Team

A

Amélie YAVCHITZ

CONTACT

A

Aurélia POUJOIS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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