NCT00819845

Ramipril Versus Carvedilol in Duchenne and Becker Patients

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Catholic University, Italy · Academic / Other
• Sex: Male
• Age: 2 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Data on preventive therapy in Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD) affected individuals without cardiac involvement are very limited and currently lacking regard both ACE-inhibitors and Beta-Blockers in Becker Muscular Dystrophy and for the latter even in Duchenne Muscular Dystrophy patients. Thus, the study aim is to compare the efficacy of carvedilol vs ramipril on myocardial tissue properties and heart function, performing CMR and myocardial Ultrasound Tissue Characterisation analysis.

Detailed description

This protocol represent an open randomized and prospective trial, designed to answer the specific question regarding the role of the cardioprotective therapy in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy patients. In this light, CMR could provide relevant data, reinforcing the scientific background, to start early (particularly in BMD patients in whom this is still a debated question) a cardioprotective treatment with carvedilol or ramipril.Finally,this clinical trial will clarify whether a preventive therapy may be helpful on the clinical outcome, both in reducing myocardial fibrosis and preventing the progression towards the cardiomyopathy.

Conditions

• Duchenne Muscular Dystrophy
• Becker Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	carvedilol	carvedilol vs ramipril
DRUG	ramipril	carvedilol vs ramipril

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-06-01
• Completion: 2016-12-01
• First posted: 2009-01-09
• Last updated: 2016-01-28

Locations

1 site across 1 country: Italy