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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02020954
Acronym
Becker-HS
Enrollment
100
Registered
2013-12-25
Start date
2013-01-31
Completion date
2017-06-30
Last updated
2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy, Heart Failure, Lef Ventricular Dysfunction

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.

Interventions

PROCEDUREECG, echocardiography, cardiac MRI, sera biomarkers

Sponsors

Institut de Myologie, France
CollaboratorOTHER
Karim WAHBI
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fraction3 years

Secondary

MeasureTime frame
Composite endpoint: hospitalisation for heart failure, death due to heart failure3 years

Countries

France

Contacts

Primary ContactKarim Wahbi, MD, PhD
karim.wahbi@cch.aphp.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026