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Heart drug fails to shield duchenne boys from cardiac decline

NCT ID NCT01648634

Prevention Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether nebivolol, a beta-blocker heart drug, could prevent heart failure in 51 boys aged 10-15 with Duchenne muscular dystrophy. Participants had normal heart function at the start and were randomly given either nebivolol or a placebo. The trial found that nebivolol did not prevent the development of heart problems compared to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

51 people

The number who actually took part.

Started

Feb 2012

Finished

Jul 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 15 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiomyopathy Duchenne muscular dystrophy heart failure systolic heart failure prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiomyopathy Duchenne muscular dystrophy Heart failure

Contacts and locations

Locations

  • Armand Trousseau Hospital

    Paris, 75012, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.