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Completed

NCT Number: NCT01648634

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

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.

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Key information

Conditions

Duchenne Muscular Dystrophy Cardiomyopathies Cardiomyopathy Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heart Diseases Heart Failure Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

10 year–15 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Armand Trousseau Hospital

Paris, 75012, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebivolol

Drug

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)

Placebo

Drug

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)

Primary outcomes

  1. Left ventricular systolic dysfunction

    Time frame: at 5 years

    Development of left ventricular systolic dysfunction with an ejection fraction < 45%

Secondary outcomes

  1. Right ventricular ejection fraction

    Time frame: at 5 years

    Right ventricular ejection fraction assessed by radionuclide angiography or echocardiography

  2. NT-ProBNP

    Time frame: at 1, 2, 3, 4, and 5 years

    NT-ProBNP

  3. Left ventricular dysfunction

    Time frame: at 10 years

    Development of left ventricular dysfunction

  4. Hospitalizations

    Time frame: at 10 years

    hospitalizations for heart failure

  5. Mortality

    Time frame: at 10 years ((5-years open label extension)

    Cardiovascular mortality

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Association Française contre les Myopathies (AFM), Paris
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: NEBIDYS

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2012
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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