Clinical Trials in France / NCT05493605
Recruiting
Not applicable
Cardiac Involvement in Wilson's Disease
NCT05493605 · tracked via the Priya Life Science France tracker
Condition(s) studied
Wilson's Disease
Investigational drug(s) / intervention(s)
Delivery of a long-term Holter 21 days Or placement of an implantable holter from the outset so syncope
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.
Study summary
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
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
Primary outcome measure(s)
- Contrast-enhanced cardiac MRI - Day 0 — Day 0
Percentage of patients with abnormal contrast-enhanced cardiac MRI results - Contrast-enhanced cardiac MRI - Day 0 — Day 0
Description of abnormalities (frequency and percentage) - Transthoracic echocardiography - Day 0 — Day 0
Percentage of patients with abnormal transthoracic echocardiography results - Transthoracic echocardiography - Day 0 — Day 0
Description of abnormalities (frequency and percentage) - Chest computed tomography scan without contrast - Day 0 — Day 0
Percentage of patients with abnormal coronary artery calcium score Calcium score : The higher the coronary calcium score, the greater the cardiovascular risk. A score of 0 (min) means that no calcium is seen in the heart. A score greater than 300 is a sign of very high to severe disease. - Electrocardiogram - Day 0 — Day 0
Percentage of patients with abnormal electrocardiogram results - Electrocardiogram - Day 0 — Day 0
Description of abnormalities (frequency and percentage) - Clinical examination - Day 0 — Day 0
Percentage of patients with abnormal clinical examination - Clinical examination - Day 0 — Day 0
Description of abnormalities (frequency and percentage) - Blood and urine tests - Day 0 — Day 0
Percentage of patients with abnormal blood and urine tests results Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria - Blood and urine tests - Day 0 — Day 0
Description of abnormalities (frequency and percentage) Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria - Lying and standing blood pressure tests - Day 0 — Day 0
Percentage of patients with abnormal blood pressure tests results - Lying and standing blood pressure tests - Day 0 — Day 0
Description of abnormalities (frequency and percentage) - Implantable loop recorder or ECG holter recorder- Day 21 — Day 21
Percentage of patients with abnormal implantable loop record (or ECG holter record) The device will record from Day 0 to Day 21 Implantable loop recorder assessment will be only performed on patients with syncope. - Implantable loop recorder or ECG holter recorder- Day 21 — Day 21
Description of abnormalities (frequency and percentage) The device will record from Day 0 to Day 21 Implantable loop recorder assessment will be only performed on patients with syncope. - Transthoracic echocardiography - Year 3 — Year 3
Percentage of patients with abnormal transthoracic echocardiography results - Transthoracic echocardiography - Year 3 — Year 3
Description of abnormalities (frequency and percentage) - Contrast-enhanced cardiac MRI - Year 3 — Year 3
Percentage of patients with abnormal contrast-enhanced cardiac MRI results - Contrast-enhanced cardiac MRI - Year 3 — Year 3
Description of abnormalities (frequency and percentage) - Chest computed tomography scan without contrast - Year 3 — Year 3
Percentage of patients with abnormal coronary artery calcium score Calcium score : The higher the coronary calcium score, the greater the cardiovascular risk. A score of 0 (min) means that no calcium is seen in the heart. A score greater than 300 is a sign of very high to severe disease. - Electrocardiogram - Year 3 — Year 3
Percentage of patients with abnormal electrocardiogram results - Electrocardiogram - Year 3 — Year 3
Description of abnormalities (frequency and percentage) - Clinical examination - Year 3 — Year 3
Percentage of patients with abnormal clinical examination - Clinical examination - Year 3 — Year 3
Description of abnormalities (frequency and percentage) - Blood and urine tests - Year 3 — Year 3
Percentage of patients with abnormal blood or urine tests results Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria - Blood and urine tests - Year 3 — Year 3
Description of abnormalities (frequency and percentage) Blood tests performed : lipid profile, glycosylated hemoglobin (HbA1C), cardiac enzymes (troponin C, NT-proBNP), ultra-sensitive C-reactive protein, sodium level, potassium level, urea and creatinine clearance, TSH, fibrinogen Urine test performed : proteinuria - Lying and standing blood pressure tests - Year 3 — Year 3
Percentage of patients with abnormal blood pressure tests results - Lying and standing blood pressure tests - Year 3 — Year 3
Description of abnormalities (frequency and percentage)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fondation Adolphe de Rothschild | Paris | France | Recruiting |
More Fondation Ophtalmologique Adolphe de Rothschild trials in France
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05493605 on ClinicalTrials.gov ↗ ← All trials in France