NCT01648634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

9.4 years

First QC Date

July 20, 2012

Last Update Submit

November 17, 2025

Conditions

Duchenne Muscular DystrophyCardiomyopathyHeart Failure

Keywords

Nebivololbeta-blockade treatment

Outcome Measures

Primary Outcomes (1)

  • Left ventricular systolic dysfunction

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

    at 5 years

Secondary Outcomes (5)

  • Right ventricular ejection fraction

    at 5 years

  • NT-ProBNP

    at 1, 2, 3, 4, and 5 years

  • Left ventricular dysfunction

    at 10 years

  • Hospitalizations

    at 10 years

  • Mortality

    at 10 years ((5-years open label extension)

Study Arms (2)

Nebivolol

EXPERIMENTAL
Drug: Nebivolol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NebivololDRUG

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)

Nebivolol
PlaceboDRUG

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)

Placebo

Eligibility Criteria

Age10 Years - 15 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Heart rate \<50 bpm
  • nd 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armand Trousseau Hospital

Paris, 75012, France

Location

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneCardiomyopathiesHeart Failure

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Henri-Marc BECANE, MD,PhD

    Armand Trousseau Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 24, 2012

Study Start

February 13, 2012

Primary Completion

July 20, 2021

Study Completion

July 20, 2021

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)