Prospective Becker-Heart-Study

Heart Failure Clinical Trial

— Becker-HS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02020954
• Other study ID #: Becker-Heart-Study
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2013
• Last updated: March 23, 2015
• Start date: January 2013
• Est. completion date: June 2017

Study information

• Verified date: March 2015
• Source: Institut de Myologie, France
• Contact: Karim Wahbi, MD, PhD
• Email: karim.wahbi[@]cch.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Heart Failure
• Lef Ventricular Dysfunction
• Ventricular Dysfunction

Intervention

Procedure:
• ECG, echocardiography, cardiac MRI, sera biomarkers

Locations

Country	Name	City	State
France	Institut de Myologie	Paris	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Karim WAHBI	Institut de Myologie, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction		3 years	No
Secondary	Composite endpoint: hospitalisation for heart failure, death due to heart failure		3 years	No