Prospective Becker-Heart-Study (Becker-HS)

March 23, 2015 updated by: Karim WAHBI

Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular ejection fraction
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite endpoint: hospitalisation for heart failure, death due to heart failure
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karim WAHBI

Collaborators

Institut de Myologie, France

Investigators

  • Principal Investigator: Karim Wahbi, MD, PhD, Institut de Myologie, Cochin Hospital, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 25, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Becker-Heart-Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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