A study to compare the efficacy of two heart drugs in Duchenne and Becker muscular dystrophies
- Condition: Duchenne muscular dystrophy and Becker muscular dystrophy
- Start Date: December 2008
- Expected End Date: December 2011
- Status: Recruiting
- Location of trial: Europe
What is the aim of the trial?
Many boys and men with Duchenne and Becker muscular dystrophy will experience heart problems as a result of their condition. Two main types of drug are used to treat and delay the onset of heart problems - ACE inhibitors and beta-blockers. These drugs do slightly different things. ACE inhibitors reduce blood pressure, which in turn puts less strain on the heart. Beta-blockers reduce the force at which the heart beats and slow the heart rate, therefore reducing the workload on the heart. Although these drugs are now often routinely used in Duchenne and Becker muscular dystrophies, no trials have been carried out to determine if they could have a protective effect on the heart if given before problems arise. This trial aims to examine how well two drugs - one ACE inhibitor (Ramipril) and one beta-blocker (Carvedilol) – are able to maintain heart function and protect against damage.
Who can be involved in the trial?
The trial is open to males aged between 2 and 45 years of age with a confirmed diagnosis of Duchenne or Becker muscular dystrophy. The participants should have no evidence of current heart problems and should not be on any heart medication.
For more information about how to get involved in trials please read our FAQ.
What happens during the trial?
The organisers are hoping to enrol 194 participants. The participants will be divided into two groups with the first group receiving Ramipril and the second group receiving Carvedilol.
Participants will have to undergo a number of examinations and follow-up appointments. The examinations will involve some non-invasive imaging of the participants’ hearts using ultrasound and cardiac magnetic resonance.
Where is the study taking place?
The study is taking place in Italy at the Unione Italiana lotta Distrofia Muscolare in Rome.
In most circumstances, for somebody to participate in a clinical trial, they need to live near the team of people who are conducting the research, because they need to be closely monitored.
How could the results of the trial benefit patients?
Heart disease is a major cause of death among people with muscular dystrophy so finding the optimal regime of heart drugs for patients is important to improve quality and length of life. The outcome of the trial could provide evidence as to whether there it is beneficial for patients to start treatment with ACE inhibitors or beta-blockers before there is evidence of any heart problems.
Catholic University, Italy
Tel: +39 (0)6 660 4881
Who is funding this study?
- Catholic University, Italy
Official name of the Trial:
Effects of Cardioprotective Therapy, Carvedilol vs Ramipril, in Patients Affected by Duchenne and Becker Muscular Dystrophy. Clinical Significance and Prognostic Value of Cardiac Magnetic Resonance Study.
Trial study number:
Further trial details:
For further information on the trial and detailed inclusion and exclusion please click on the link below. Sometimes these details can be quite technical. If you have any questions please discuss this with your clinician or contact the clinical trial organisers.
Background information and related links:
- More information about Duchenne muscular dystrophy
- More information about Becker muscular dystrophy
- Download our “Heart Check” factsheet