Actively Recruiting
Cardiac Involvement in Wilson's Disease
Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-12-17
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating cardiac involvement in adults with Wilson's Disease, a condition where copper builds up in the body. Although heart damage from copper accumulation has been reported, especially in adults, previous studies with small patient numbers showed limited data. The study explores whether heart problems, including rhythm abnormalities and structural changes, occur over time and need specific monitoring and care. The study involves cardiological follow-up using long-term heart rhythm monitoring. Participants will wear a 21-day Holter monitor to record heart rhythms and detect irregularities. Some patients may also have an implantable cardiac monitor placed to track heart activity continuously. These procedures aim to identify arrhythmias and conduction issues associated with Wilson's Disease. Participants will undergo various assessments at the start and after three years, including contrast-enhanced cardiac MRI, echocardiography, chest CT scans without contrast, electrocardiograms, blood and urine tests, clinical examinations, and lying and standing blood pressure measurements. Heart rhythm monitoring will be done with Holter or implantable loop recorders. This comprehensive evaluation will help researchers understand heart involvement and guide future screening and support strategies. The study is expected to run until March 2026.
CONDITIONS
Brief Title
Cardiac Involvement in Wilson's Disease
Who Can Participate
Eligibility Criteria
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 case of guardianship
- Member or beneficiary of a Social Security scheme
You will not qualify if you...
- Absolute or relative contraindication to MRI or contrast media
- Pregnant, parturient, or breastfeeding women
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days
Participants undergo cardiac monitoring using a long-term Holter worn for 21 days or an implantable cardiac monitor to record heart rhythm and detect arrhythmias or conduction disorders.
1 to 2 visits depending on monitoring device placement
Duration - Up to 3 years
Participants receive follow-up cardiac assessments including imaging and clinical examinations at 3 years after initial monitoring.
1 visit at Year 3 (in-person)
Trial Site Locations
Total: 1 location
1
Fondation Adolphe de Rothschild
Paris, France, 75019
Actively Recruiting
Research Team
A
Amélie YAVCHITZ
A
Aurélia POUJOIS
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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