Prospective Becker-Heart-Study

• Conditions: Lef Ventricular Dysfunction; Heart Failure; Dilated Cardiomyopathy
• Interventions: Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers

• Registration Number: NCT02020954
• Lead Sponsor: Karim WAHBI

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• mutation in the DMD gene
• Becker muscular dystrophy and/or dilated cardiomyopathy
• age>18 years
• affiliation to the French medical insurance

Exclusion Criteria

• Duchenne muscular dystrophy
• Any other chronic disease that may be associated with heart disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dystrophinopathy	ECG, echocardiography, cardiac MRI, sera biomarkers	Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	3 years

Secondary Outcome Measures

Name	Time	Method
Composite endpoint: hospitalisation for heart failure, death due to heart failure	3 years

Trial Locations

Locations (1)

Institut de Myologie; 🇫🇷 Paris, Ile de France, France