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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Hospital Rudolfstiftung.
Recruitment status was  Recruiting
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 22, 2012
Last verified: October 2012
  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 Hospital Rudolfstiftung:

Primary Outcome Measures:
  • T1 mapping [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    left ventricular function on MRI will be compared between study entry and one year follow-up


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Contacts
Contact: Paul Wexberg, MD +43-1-71165 ext 92277 paul.wexberg@wienkav.at

Locations
Austria
2nd Medical Dept., Rudolfstiftung Recruiting
Vienna, Austria, A-1030
Principal Investigator: Paul Wexberg, MD         
Sub-Investigator: Marion Avanzini, MD         
Sponsors and Collaborators
Hospital Rudolfstiftung
Oesterreichische Muskelforschung
  More Information

No publications provided

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 22, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Hospital Rudolfstiftung:
Duchenne muscular dystrophy
carrier
cardiac MRI
myocardial fibrosis
female

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

ClinicalTrials.gov processed this record on October 23, 2014