Prospective Becker-Heart-Study

NCT ID: NCT02020954

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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

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Dilated Cardiomyopathy Lef Ventricular Dysfunction Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dystrophinopathy

Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy

ECG, echocardiography, cardiac MRI, sera biomarkers

Intervention Type PROCEDURE

Interventions

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ECG, echocardiography, cardiac MRI, sera biomarkers

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institut de Myologie, France

OTHER

Sponsor Role collaborator

Karim WAHBI

OTHER

Sponsor Role lead

Responsible Party

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Karim WAHBI

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karim Wahbi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Myologie, Cochin Hospital, Paris

Locations

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Institut de Myologie

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Karim Wahbi, MD, PhD

Role: CONTACT

Facility Contacts

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Nawal Berber, PhD

Role: primary

References

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Marty B, Baudin PY, Caldas de Almeida Araujo E, Fromes Y, Wahbi K, Reyngoudt H. Assessment of Extracellular Volume Fraction in Becker Muscular Dystrophy by Using MR Fingerprinting. Radiology. 2023 May;307(3):e221115. doi: 10.1148/radiol.221115. Epub 2023 Mar 7.

Reference Type DERIVED
PMID: 36880945 (View on PubMed)

Other Identifiers

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Becker-Heart-Study

Identifier Type: -

Identifier Source: org_study_id

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