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Cardiac Involvement in Wilson's Disease

Study acronym: WIL-HEART
StatusRecruiting
PhaseNot applicable
Started2023-03-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 35 months later Mar 2026 → Mar 2029
See other at-risk trials from Fondation Ophtalmologique Adolphe de Rothschild

Amendment history

2026-10-02
critical
Primary completion pushed: 2026-03 → 2029-03
Completion pushed: 2026-03 → 2029-03
2025-12-09
minor
2 amendments v3-v4
2 re-verifications since 2024-06-03, no change to tracked fields
2023-05-10
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-03→confirmed 2023-03-02
Study sites0→1
2023-02-11
minor
Study Status v1
Primary completion date2025-09→2026-03
Completion date2025-09→2026-03
Start date2022-09→2023-03
2022-08-08
minor
Original filing
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.
Trial Details
NCT Number NCT05493605
Lead Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Conditions Wilson's Disease
Enrollment 150 participants
Start Date 2023-03-02
Primary Completion 2029-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-10-01