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

This study has been completed.
Sponsor:
Collaborator:
Oesterreichische Muskelforschung
Information provided by (Responsible Party):
Paul Wexberg,MD, Hospital Rudolfstiftung
ClinicalTrials.gov Identifier:
NCT01712152
First received: October 19, 2012
Last updated: October 3, 2016
Last verified: October 2016
  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.

Condition
Carrier of Duchenne Muscular Dystrophy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Paul Wexberg,MD, Hospital Rudolfstiftung:

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


Enrollment: 20
Study Start Date: October 2012
Study Completion Date: September 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712152

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Wexberg,MD, Priv.-Doz., Hospital Rudolfstiftung
ClinicalTrials.gov Identifier: NCT01712152     History of Changes
Other Study ID Numbers: EK 11-228- 0112
Study First Received: October 19, 2012
Last Updated: October 3, 2016

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

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

ClinicalTrials.gov processed this record on August 23, 2017