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Completed

NCT Number: NCT01712152

Myocardial Involvement in Carriers of Duchenne Muscular Dystrophy: An MRI-study

Carriers of Duchenne muscular dystrophy (DMD) often have no severe symptoms of the scelet muscles, but they may develop a poor heart function due to the involvement of the heart muscle. Ultrasound of the heart is recommended, but it can detect a cardiac affection only after the heart has already become weaker. Cardiac magnetic resonance tomography can detect myocardial fibrosis already at preserved heart function and may facilitate early therapy. In our study, diagnosed carriers of DMD will undergo examinations of the heart by blood tests, EKG, heart ultrasound and magnetic resonance at enrollment and after one year in order to assess the extent of cardiac affection and its association with the clinical development.

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Key information

Conditions

Carrier of Duchenne 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

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

2nd Medical Dept., Rudolfstiftung

Vienna, A-1030, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

genetic and/or histological identification as a carrier of DMD age above 18 years able and willing to conform to the requirements of the study provided written informed consent exclusion of pregnancy in women of childbearing potential

Exclusion criteria

Claustrophobia Excessive obesity to an extent where CMR cannot be performed Chronic renal failure with a GFR <30 ml/min/1,73m² Implanted pacemakers/defibrillators Severe arrhythmia Inability to cooperate during the CMR Known intolerance to gadolinium Positive pregnancy test Unable or unwilling to conform to the study protocol

Treatment and study plan

Primary outcomes

  1. T1 mapping

    Time frame: 1 year

    T1 mapping by MOLLI sequences will be performed and compared between study entry and one year follow-up

Secondary outcomes

  1. left ventricular function

    Time frame: 1 year

    left ventricular function on MRI will be compared between study entry and one year follow-up

Sponsors and collaborators

Lead sponsor

Hospital Rudolfstiftung

Other

Collaborators

  • Oesterreichische Muskelforschung

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Oct 23, 2012
Registry last updated
Oct 4, 2016

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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