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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712152
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : October 4, 2016
Oesterreichische Muskelforschung
Information provided by (Responsible Party):
Paul Wexberg,MD, Hospital Rudolfstiftung

Brief Summary:
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.

Condition or disease
Carrier of Duchenne Muscular Dystrophy

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2015

Primary Outcome Measures :
  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 Outcome Measures :
  1. left ventricular function [ Time Frame: 1 year ]
    left ventricular function on MRI will be compared between study entry and one year follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
data base of carriers of Duchenne muscular dystrophy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712152

2nd Medical Dept., Rudolfstiftung
Vienna, Austria, A-1030
Sponsors and Collaborators
Hospital Rudolfstiftung
Oesterreichische Muskelforschung
Study Director: Paul Wexberg, MD Hospital Rudolfstiftung

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paul Wexberg,MD, Priv.-Doz., Hospital Rudolfstiftung Identifier: NCT01712152     History of Changes
Other Study ID Numbers: EK 11-228- 0112
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Keywords provided by Paul Wexberg,MD, Hospital Rudolfstiftung:
Duchenne muscular dystrophy
cardiac MRI
myocardial fibrosis

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked