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

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

key information

study id #: NCT01712152

condition: Carrier of Duchenne Muscular Dystrophy

status: completed

purpose:

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.

mechanism of action: No pharmaceutical intervention

results: https://clinicaltrials.gov/ct2/show/results/NCT01712152

last updated: November 22, 2018

study details

start date: October 2012

estimated completion: April 2014

size / enrollment: 20

primary outcomes:

  • 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:

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

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

study contacts

sponsor: Hospital Rudolfstiftung

investigators: Paul Wexberg, MD

locations: Austria

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