Prospective Becker-Heart-Study (Becker-HS)
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|ClinicalTrials.gov Identifier: NCT02020954|
Recruitment Status : Unknown
Verified March 2015 by Karim WAHBI, Institut de Myologie, France.
Recruitment status was: Recruiting
First Posted : December 25, 2013
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment|
|Dilated Cardiomyopathy Lef Ventricular Dysfunction Heart Failure||Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy
|Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers|
- Left ventricular ejection fraction [ Time Frame: 3 years ]
- Composite endpoint: hospitalisation for heart failure, death due to heart failure [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020954
|Contact: Karim Wahbi, MD, PhDemail@example.com|
|Institut de Myologie||Recruiting|
|Paris, Ile de France, France, 75013|
|Contact: Nawal Berber, PhD firstname.lastname@example.org|
|Principal Investigator: Karim Wahbi, MD, PhD|
|Principal Investigator:||Karim Wahbi, MD, PhD||Institut de Myologie, Cochin Hospital, Paris|