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Cardiac Involvement in Wilson's Disease

NCT ID: NCT05493605

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Wilson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients with confirmed Wilson Disease presenting for consultation or hospitalization for their follow-up or at the time of diagnosis will be offered to participate in the study.

Patients who have already benefited from a cardiac assessment with installation of an implantable Holter ECG as part of the treatment may be included retrospectively
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cases

The intervention consists in setting up a morphological and rhythmological cardiological follow-up patients with confirmed Wilson disease. It will require the wearing of a long Holter duration (21 days) and for some patients the installation of an implantable cardiac monitor.The long-time ECG holter is used to record heart rhythm for 21 days and detect possible arrhythmias (accelerations of the heart) or conduction disorders (slowdowns of the heart).

Group Type OTHER

Delivery of a long-term Holter 21 days Or placement of an implantable holter from the outset so syncope

Intervention Type PROCEDURE

The intervention consists of setting up a morphological and rhythmological cardiological follow-up of patients with confirmed Wilson's disease. It will require the wearing of a long-term Holter (21 days) and for some patients the installation of an implantable cardiac monitor.

Interventions

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Delivery of a long-term Holter 21 days Or placement of an implantable holter from the outset so syncope

The intervention consists of setting up a morphological and rhythmological cardiological follow-up of patients with confirmed Wilson's disease. It will require the wearing of a long-term Holter (21 days) and for some patients the installation of an implantable cardiac monitor.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Adolphe de Rothschild

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Amélie YAVCHITZ

Role: CONTACT

[email protected]
01 48 03 64 54

Aurélia POUJOIS

Role: CONTACT

[email protected]
01 48 30 66 56

Facility Contacts

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Aurélia Poujois

Role: primary

[email protected]
0148036656

Other Identifiers

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APS_2021_9

Identifier Type: -

Identifier Source: org_study_id