Cardiac Involvement in Wilson's Disease
ConditionWilson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondation Ophtalmologique Adolphe de Rothschild
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Delivery of a long-term Holter 21 days Or placement of an implantable holter from the outset so syncope
Procedure/SurgeryThe 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: CasesOther 1 intervention
Trial outcomes
Primary outcomes
1
Contrast-enhanced cardiac MRI - Day 0
Percentage of patients with abnormal contrast-enhanced cardiac MRI results
Time frame
Day 02
Contrast-enhanced cardiac MRI - Day 0
Description of abnormalities (frequency and percentage)
Time frame
Day 03
Transthoracic echocardiography - Day 0
Percentage of patients with abnormal transthoracic echocardiography results
Time frame
Day 04
Transthoracic echocardiography - Day 0
Description of abnormalities (frequency and percentage)
Time frame
Day 0Sponsors and contacts
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Source ClinicalTrials.gov