NCT02020954

Prospective Becker-Heart-Study

Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Karim WAHBI · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.

Detailed description

A cohort of 100 patients with mutations in the dystrophin gene associated with Becker muscular dystrophy and/or dilated cardiomyopathy will be included (patients with Duchenne muscular dystrophy are excluded). Patients with undergo at baseline the following workups: electrocardiogram, echocardiography, cardiac MRI, sera biomarkers measurement. At 3 years and 5 years, patients will be investigated according to the same protocol and occurrence of cardiac adverse events in the meanwhile will be recorded. Statistical analysis will assess correlations between cardiac phenotype and DMD mutations and prognostic value of cardiac investigations.

Conditions

• Dilated Cardiomyopathy
• Lef Ventricular Dysfunction
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	ECG, echocardiography, cardiac MRI, sera biomarkers

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-12-25
• Last updated: 2015-03-24

Locations

1 site across 1 country: France