Prospective Becker-Heart-Study | NCT02020954

Studies
Prospective Becker-Heart-Study

NCT02020954

Sponsor

Karim WAHBI

Status

Unknown status

Last Update Posted

Mar 24, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Dilated Cardiomyopathy
Lef Ventricular Dysfunction
Heart Failure

Interventions

ECG, echocardiography, cardiac MRI, sera biomarkers

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Dec 19, 2013

First Submission Date that Met QC Criteria

Dec 19, 2013

First Posted Date

Dec 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2015

Last Update Posted Date

Mar 24, 2015Estimated

Name	Class
Institut de Myologie, France	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dystrophinopathy		Patients with mutations in the DMD gene and Becker muscular dystrophy and/or dilated cardiomyopathy	Procedure: ECG, echocardiography, cardiac MRI, sera biomarkers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECG, echocardiography, cardiac MRI, sera biomarkers	Procedure		Dystrophinopathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular ejection fraction		3 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karim Wahbi, MD, PhD	Contact			karim.wahbi@cch.aphp.fr

Overall Officials

Name	Affiliation	Role
Karim Wahbi, MD, PhD	Institut de Myologie, Cochin Hospital, Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut de Myologie	Recruiting	Paris	Île-de-France Region	75013	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36880945	Derived	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.

ID	Term
D002311	Cardiomyopathy, Dilated
D006333	Heart Failure

ID	Term
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009202	Cardiomyopathies