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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
Sponsor:
Collaborator:
Institut de Myologie, France
Information provided by (Responsible Party):
Karim WAHBI, Institut de Myologie, France

Study Description
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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.

Condition or disease Intervention/treatment
Dilated Cardiomyopathy Lef Ventricular Dysfunction Heart Failure Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Dystrophinopathy
Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy
 Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Composite endpoint: hospitalisation for heart failure, death due to heart failure [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Karim Wahbi, MD, PhD karim.wahbi@cch.aphp.fr

Locations
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France
Institut de Myologie Recruiting
Paris, Ile de France, France, 75013
Contact: Nawal Berber, PhD       n.benammar@institut-myologie.org   
Principal Investigator: Karim Wahbi, MD, PhD         
Sponsors and Collaborators
Karim WAHBI
Institut de Myologie, France
Investigators
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Principal Investigator: Karim Wahbi, MD, PhD Institut de Myologie, Cochin Hospital, Paris
More Information
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Responsible Party: Karim WAHBI, MD, PhD, Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT02020954    
Other Study ID Numbers: Becker-Heart-Study
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Cardiomyopathies
Ventricular Dysfunction
Cardiomyopathy, Dilated
 Heart Diseases
Cardiovascular Diseases
Cardiomegaly