Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy

• Status: Completed
• Trial end date: 2021-07-20
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Association Française contre les Myopathies (AFM), Paris
• Treatments: Nebivolol

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

• Participation to another clinical trial within 3 months