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Completed

NCT Number: NCT02470962

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.

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Key information

Conditions

Duchenne / Becker Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

8 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Children's Hospital

Zurich, Canton of Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Observation by serial echocardiography with extended techniques and cardiac magnetic resonance imaging

Primary outcomes

  1. Left ventricular ejection fraction

    Time frame: 3 years per patient

Secondary outcomes

  1. Quantification of fibrosis by LGE/T1 mapping

    Time frame: 3 years per patient

  2. NT-proBNP

    Time frame: 3 years per patient

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2015
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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