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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020047-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Association Française contre les Myopathies (AFM), Paris | OTHER |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15 year-old.
A 1.25 mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol and placebo will be performed with 2 weeks periods. Full dose of nebivolol and placebo is 5mg/day (7.5mg/day for patients whose weight is>60kg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | A 1.25mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol will be performed with 2 weeks periods. Full dose of nebivolol is 5mg/day (7.5mg/day for patients whose weight is>60kg) |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular systolic dysfunction | Development of left ventricular systolic dysfunction with an ejection fraction < 45% | at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Right ventricular ejection fraction | Right ventricular ejection fraction assessed by radionuclide angiography or echocardiography | at 5 years |
| NT-ProBNP | NT-ProBNP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henri-Marc BECANE, MD,PhD | Armand Trousseau Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armand Trousseau Hospital | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | A 1.25mg-test dose of nebivolol will be administrated to assess the treatment tolerance before randomization. A forced titration of placebo will be performed with 2 weeks periods. Full dose of placebo is 5mg/day (7.5mg/day for patients whose weight is>60kg) |
|
| at 1, 2, 3, 4, and 5 years |
| Left ventricular dysfunction | Development of left ventricular dysfunction | at 10 years |
| Hospitalizations | hospitalizations for heart failure | at 10 years |
| Mortality | Cardiovascular mortality | at 10 years ((5-years open label extension) |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |