Duchenne Muscular Dystrophy Heart Study

Duchenne Muscular Dystrophy Clinical Trial

— DMD-HS  

Official title:

Multicenter Cohort Study on Duchenne Muscular Dystrophy Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03443115
• Other study ID #: DMD-HS
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2018
• Last updated: February 16, 2018
• Start date: June 27, 2017
• Est. completion date: March 15, 2020

Study information

• Verified date: February 2018
• Source: Hôpital Cochin
• Contact: Karim Wahbi, MD, PhD
• Phone: +33158411653
• Email: karim.wahbi[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective cohort study including patients with genetically proven Duchenne muscular dystrophy, diagnosed from January 1993 to March 2020.

Inclusion of the data relative to genetic diagnosis, clinical characteristics at baseline, cardiac and respiratory workup, medical treatments (ACE inhibitors, steroids), surgical procedures, and occurrence during follow-up of cardiac, respiratory and fatal events.

Objectives are to describe long-term natural history of the disease, vital prognosis, genotype-phenotype correlations, effect of treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: March 15, 2020
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Genetically-proven Duchenne Muscular Dystrophy (DMD mutation)

• Covering by social security

Exclusion Criteria:

• Patient refusal to participate to the study

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Duchenne Muscular Dystrophy
• Duchenne Muscular Dystrophy-Associated Dilated Cardiomyopathy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Locations

Country	Name	City	State
France	Cochin Reference Center for Neuromuscular Diseases	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital Cochin	Association Monégasque contre les Myopathies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		Follow-up completed in March 2020
Secondary	Hospitalization for heart failure		Follow-up completed in March 2020
Secondary	Dilated cardiomyopathy		Follow-up completed in March 2020
Secondary	Hospitalization for acute respiratory failure		Follow-up completed in March 2020