Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne M… (NCT01648634) | Clinical Trial Compass
CompletedPhase 3
Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
France51 participantsStarted 2012-02-13
Plain-language summary
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.
Who can participate
Age range10 Years – 15 Years
SexMALE
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Inclusion Criteria:
* Duchenne muscular dystrophy genetically proven
* Age between 10 and 15 years
* Left ventricular ejection fraction assessed by radionuclide angiography or echocardiography ≥50% and measured within 3 months
* Systolic blood pressure ≥80 mmHg
* Diastolic blood pressure ≥70 mmHg
Exclusion Criteria:
* Heart rate \<50 bpm
* 2nd or 3rd degree atrioventricular blocks, sinus node dysfunction
* Asthma or bronchospasm
* Severe peripheral circulatory disease
* Hypersensitivity to nebivolol or excipients
* Metabolic acidosis
* Blood urea \>7 mmol/l
* Liver transaminases enzymes \>6 fold the upper limit of normal
* Formal indication for beta-blockade treatment
* Cardiac treatments except angiotensin-converting enzyme inhibitors
* Participation to another clinical trial within 3 months