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Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT02470962
Recruitment Status : Recruiting
First Posted : June 12, 2015
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

June 10, 2015
June 12, 2015
May 24, 2018
May 2015
April 2020   (Final data collection date for primary outcome measure)
Left ventricular ejection fraction [ Time Frame: 3 years per patient ]
Same as current
Complete list of historical versions of study NCT02470962 on ClinicalTrials.gov Archive Site
  • Quantification of fibrosis by LGE/T1 mapping [ Time Frame: 3 years per patient ]
  • NT-proBNP [ Time Frame: 3 years per patient ]
Same as current
Not Provided
Not Provided
 
Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy
Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy
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.
Muscular dystrophy leads to progressive loss of function in all muscles during childhood and adolescence, including the heart. The usual method to evaluate the heart is echocardiography, emphasizing few parameters. Cardiac magnetic resonance imaging is not as widely available as echocardiography, but early changes can be detected before they become visible on echocardiography. In this study, the investigators compare the methods of measuring heart function in order to find the best measurements for follow up and to see how fast the degenerative changes occur in the hearts of patients with muscular dystrophy.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  • Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
  • Control group for CMR: children without heart disease
Duchenne / Becker Muscular Dystrophy
Other: Observation
Observation by serial echocardiography with extended techniques and cardiac magnetic resonance imaging
  • 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
    Intervention: Other: Observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
April 2020
April 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
  • Informed consent

Exclusion Criteria:

  • 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
Sexes Eligible for Study: Male
8 Years to 18 Years   (Child, Adult)
Yes
Contact: Hilfiker Silvia +41442663339 silvia.hilfiker@kispi.uzh.ch
Switzerland
 
 
NCT02470962
DMD-Herz
No
Not Provided
Not Provided
University Children's Hospital, Zurich
University Children's Hospital, Zurich
Not Provided
Principal Investigator: Barbara EU Burkhardt, MD Children's Hospital Zürich, Switzerland
University Children's Hospital, Zurich
May 2018