Natural History of Duchenne Muscular Dystrophy Cardiomyop... | NCT05558813

Studies
Natural History of Duchenne Muscular Dystrophy Cardiomyopathy (DMD-CMP)

NCT05558813

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Last Update Posted

Nov 20, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Duchenne Muscular Dystrophy

Interventions

Cardiac MRI
Blood assays

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

ID	Type	Description	Link
2020-A03534-35	Other Identifier	ID-RCB Number

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Cancellation of financing by the financier.

Expanded Access Info

Start Date

Nov 2024Estimated

Primary Completion Date

Feb 2029Estimated

Completion Date

Apr 2029Estimated

First Submitted Date

Apr 15, 2022

First Submission Date that Met QC Criteria

Sep 26, 2022

First Posted Date

Sep 28, 2022Actual

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

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.

Detailed Description

This study is to describe the progression of tissular (late gadolinium enhancement, T1, T2, ECV assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin I, NTproBNP). Comparison between baseline and 2-years assessments will be conducted.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DMD-CMP cohort	Experimental	Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy	Diagnostic Test: Cardiac MRI Biological: Blood assays

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac MRI	Diagnostic Test	two cardiac MRIs with Gadolinum injection at 2-year intervals	DMD-CMP cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Late gadolinium enhancement burden on cardiac MRI		2 years

Secondary Outcomes

Measure	Description	Time Frame
Global T1 on cardiac MRI		2 years
Global T2 on cardiac MRI		2 years
Global extracellular volume on cardiac MRI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

Age >= 6 years
Genetically proven Duchenne muscular dystrophy
Affiliation to French medical insurance
Informed consent provided

Exclusion Criteria :

Age <6 years
Left ventricular ejection fraction <30%
Tracheostomy of hospitalisation for acute respiratory failure <1 year
Contraindication to MRI: claustrophobia, Gadolinum allergy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karim A WAHBI, MD, PhD	APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Necker Hospital		Paris		75015	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020388	Muscular Dystrophy, Duchenne
D009202	Cardiomyopathies

Ancestor Terms

ID	Term
D009136	Muscular Dystrophies
D020966	Muscular Disorders, Atrophic
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided