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

Completed

• Conditions: Carrier of Duchenne Muscular Dystrophy

• Registration Number: NCT01712152
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-23
• Primary Completion: 2014-04
• Study Completion: 2015-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T1 mapping	1 year	T1 mapping by MOLLI sequences will be performed and compared between study entry and one year follow-up

Secondary Outcome Measures

Name	Time	Method
left ventricular function	1 year	left ventricular function on MRI will be compared between study entry and one year follow-up

Trial Locations

Locations (1)

2nd Medical Dept., Rudolfstiftung; 🇦🇹 Vienna, Austria