Investigating heart issues in Wilson's Disease
Official title: Cardiac Involvement in Wilson's Disease
Run by Fondation Ophtalmologique Adolphe de Rothschild · NCT05493605 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | March 2, 2023 |
| Main results expected | March 2029 |
| Study ends | March 2029 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT05493605 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients diagnosed with Wilson's Disease who meet specific inclusion criteria.
✕Probably not a fit
Patients with severe hepatic decompensation or those in neuro-psychiatric decompensation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Fondation Adolphe de Rothschild
Paris, France Recruiting
Study contacts
- Study coordinator: Amélie YAVCHITZ
- Email: ayavhitz@for.paris
- Phone: 01 48 03 64 54
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
PM577a: a one-time gene-editing therapy for Wilson disease
This study tests PM577a, a gene-editing treatment, to see if it is safe and may help people with Wilson disease who have a p.H1069Q ATP7B mutation.
-
One-a-day trientine for newly diagnosed Wilson's disease
A new once-daily trientine formulation is being tested against d-Penicillamine as a first-line treatment for people with Wilson's disease, including both children 8 and older and adults.
-
ATP7B mRNA (DSL101) therapy for Wilson disease
This treatment will test whether one or more IV infusions of ATP7B mRNA (DSL101) are safe and help control copper in adults with genetically confirmed Wilson disease.
-
International registry for Wilson's Disease patients
This study is gathering information from people with Wilson's Disease during their regular doctor visits to better understand the disease and how patients are managing it.
-
Examining copper levels in breast milk of pregnant women with Wilson's disease
This study tests how treatment for Wilson's disease affects copper levels in the breast milk of pregnant women to ensure the health of both mom and baby during breastfeeding.
-
Observational study on Wilson's Disease
This study looks at how Wilson's Disease affects people in different ways to help improve care for patients and their families.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.