Investigating heart issues in Wilson's Disease
Cardiac Involvement in Wilson's Disease
This study is testing how Wilson's Disease affects the heart in adults by using long-term heart monitoring to see if copper buildup causes any problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT05493605 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the cardiac involvement in patients with Wilson's Disease, focusing on the potential heart damage caused by copper accumulation. It will utilize long-term Holter monitoring for 21 days or an implantable Holter device to assess cardiac function and identify any electrocardiographic abnormalities. The research seeks to better understand the epidemiology of cardiac issues in Wilson's Disease, particularly in adult patients, as previous studies have shown limited involvement in pediatric populations. The hypothesis is that significant cardiac manifestations may develop over time, necessitating regular screening and support.
Who should consider this trial
Good fit: Ideal candidates include adult patients diagnosed with Wilson's Disease who meet specific inclusion criteria.
Not a fit: Patients with severe hepatic decompensation or those in neuro-psychiatric decompensation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for cardiac complications in patients with Wilson's Disease.
How similar studies have performed: While previous studies have indicated potential cardiac involvement in Wilson's Disease, this study aims to provide a more comprehensive understanding, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Fondation Adolphe de Rothschild — Paris, France (Recruiting)
Study contacts
- Study coordinator: Amélie YAVCHITZ
- Email: ayavhitz@for.paris
- Phone: 01 48 03 64 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.