NCT01648634
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Examine the Effect of Nebivolol, a Beta-Blockade Drug, for the Prevention of Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
Overview
- Phase
- Phase 3
- Intervention
- Nebivolol
- Conditions
- Duchenne Muscular Dystrophy
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Left ventricular systolic dysfunction
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed Description
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Nebivolol
Intervention: Nebivolol
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Left ventricular systolic dysfunction
Time Frame: at 5 years
Development of left ventricular systolic dysfunction with an ejection fraction \< 45%
Secondary Outcomes
- Hospitalizations(at 10 years)
- NT-ProBNP(at 1, 2, 3, 4, and 5 years)
- Left ventricular dysfunction(at 10 years)
- Mortality(at 10 years ((5-years open label extension))
- Right ventricular ejection fraction(at 5 years)
Study Sites (1)
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