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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 October 2021
• Main ID: NCT01648634
• Date of registration: 20/07/2012
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy NEBIDYS
• Scientific 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
• Date of first enrolment: February 13, 2012
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01648634
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Henri-Marc BECANE, MD,PhD
• Affiliation: Armand Trousseau Hospital

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 15 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy

Cardiomyopathy

Heart Failure

Intervention(s)

Drug: Nebivolol

Drug: Placebo

Primary Outcome(s)

Left ventricular systolic dysfunction [Time Frame: at 5 years]

Secondary Outcome(s)

Left ventricular dysfunction [Time Frame: at 10 years]

Mortality [Time Frame: at 10 years ((5-years open label extension)]

Right ventricular ejection fraction [Time Frame: at 5 years]

Hospitalizations [Time Frame: at 10 years]

NT-ProBNP [Time Frame: at 1, 2, 3, 4, and 5 years]

Secondary ID(s)

2010-020047-12

P090202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Association Française contre les Myopathies (AFM), Paris