Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy
1 other identifier
observational
59
1 country
1
Brief Summary
This study evaluates the function of the heart in young patients with muscular dystrophy type Duchenne or Becker. Participants have their hearts examined at regular intervals by ultrasound (echocardiography) and cardiac magnetic resonance imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 10, 2015
CompletedFirst Posted
Study publicly available on registry
June 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2022
CompletedMarch 20, 2025
March 1, 2025
6.8 years
June 10, 2015
March 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Left ventricular ejection fraction
3 years per patient
Secondary Outcomes (2)
Quantification of fibrosis by LGE/T1 mapping
3 years per patient
NT-proBNP
3 years per patient
Study Arms (2)
Patients with muscular dystrophy
Boys aged 8 to 18 years with muscular dystrophy of the Duchenne / Becker type
Children without heart disease
Children without heart disease, aged 8-18 years, as CMR comparison group
Interventions
Observation by serial echocardiography with extended techniques and cardiac magnetic resonance imaging
Eligibility Criteria
* Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy * Control group for CMR: children without heart disease
You may qualify if:
- Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
- Informed consent
You may not qualify if:
- Other clinically significant concomitant disease states (e.g., renal failure)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or his/her parents or legal caregivers,
- Inability to lie still for the duration of the imaging procedures (approximately 45 minutes each for echocardiography and CMR)
- MR-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital
Zurich, Canton of Zurich, 8032, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara EU Burkhardt, MD
Children's Hospital Zürich, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2015
First Posted
June 12, 2015
Study Start
June 1, 2015
Primary Completion
March 22, 2022
Study Completion
March 22, 2022
Last Updated
March 20, 2025
Record last verified: 2025-03