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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
51
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)
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)
Armand Trousseau Hospital
Paris, France
Left ventricular systolic dysfunction
Development of left ventricular systolic dysfunction with an ejection fraction \< 45%
Time frame: at 5 years
Right ventricular ejection fraction
Right ventricular ejection fraction assessed by radionuclide angiography or echocardiography
Time frame: at 5 years
NT-ProBNP
NT-ProBNP
Time frame: at 1, 2, 3, 4, and 5 years
Left ventricular dysfunction
Development of left ventricular dysfunction
Time frame: at 10 years
Hospitalizations
hospitalizations for heart failure
Time frame: at 10 years
Mortality
Cardiovascular mortality
Time frame: at 10 years ((5-years open label extension)
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