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

Last updated: September 27, 2021
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

3

Condition

Heart Failure

Circulation Disorders

Muscular Dystrophy

Treatment

N/A

Clinical Study ID

NCT01648634
P090202
2010-020047-12
  • Ages 10-15
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Duchenne muscular dystrophy genetically proven
  • Age between 10 and 15 years
  • Left ventricular ejection fraction assessed by radionuclide angiography orechocardiography ≥50% and measured within 3 months
  • Systolic blood pressure ≥80 mmHg
  • Diastolic blood pressure ≥70 mmHg

Exclusion

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

Study Design

Total Participants: 51
Study Start date:
February 13, 2012
Estimated Completion Date:
July 20, 2021

Study 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).

Connect with a study center

  • Armand Trousseau Hospital

    Paris, 75012
    France

    Site Not Available

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