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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01712152

Enrollment

Registered

2012-10-23

Start date

2012-10-31

Completion date

2015-09-30

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carrier of Duchenne Muscular Dystrophy

Keywords

Duchenne muscular dystrophy, carrier, cardiac MRI, myocardial fibrosis, female

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
left ventricular function	1 year	left ventricular function on MRI will be compared between study entry and one year follow-up

Countries

Austria

Outcome results