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Duchenne Muscular Dystrophy Heart Study (DMD-HS)

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ClinicalTrials.gov Identifier: NCT03443115
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
Association Monégasque contre les Myopathies
Information provided by (Responsible Party):
Karim Wahbi, Hôpital Cochin

February 16, 2018
February 22, 2018
February 22, 2018
June 27, 2017
February 16, 2018   (Final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: Follow-up completed in March 2020 ]
Same as current
No Changes Posted
  • Hospitalization for heart failure [ Time Frame: Follow-up completed in March 2020 ]
  • Dilated cardiomyopathy [ Time Frame: Follow-up completed in March 2020 ]
  • Hospitalization for acute respiratory failure [ Time Frame: Follow-up completed in March 2020 ]
Same as current
Not Provided
Not Provided
 
Duchenne Muscular Dystrophy Heart Study
Multicenter Cohort Study on Duchenne Muscular Dystrophy Cardiomyopathy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
Consecutive patients diagnosed with Duchenne muscular dystrophy and referred to reference centers for neuromuscular diseases for the management of their condiction.
  • Duchenne Muscular Dystrophy
  • Duchenne Muscular Dystrophy-Associated Dilated Cardiomyopathy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
Same as current
March 15, 2020
February 16, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Genetically-proven Duchenne Muscular Dystrophy (DMD mutation)
  • Covering by social security

Exclusion Criteria:

  • Patient refusal to participate to the study
Sexes Eligible for Study: Male
Child, Adult, Older Adult
No
Contact: Karim Wahbi, MD, PhD +33158411653 karim.wahbi@aphp.fr
France
 
 
NCT03443115
DMD-HS
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Karim Wahbi, Hôpital Cochin
Hôpital Cochin
Association Monégasque contre les Myopathies
Not Provided
Hôpital Cochin
February 2018