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Arrhythmias in Myotonic Muscular Dystrophy (DM1)

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ClinicalTrials.gov Identifier: NCT00622453
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by:
Indiana University

Brief Summary:
Adult myotonic muscular dystrophy (Steinert's disease) is the most common inherited neuromuscular disorder. Cardiac rhythm disturbances occur frequently in this disease state and may be responsible for up to one-third of deaths. In this study, we intend to evaluate the utility of non-invasive electrocardiographic screening methods and history in predicting serious arrhythmic events.

Condition or disease Intervention/treatment
Muscular Dystrophy Arrhythmia Sudden Cardiac Death Other: Screening

Detailed Description:

The long term objectives of this population study is a more defined natural history, optimal diagnostic testing methodology, and methods of therapy for arrhythmias in individuals with myotonic muscular dystrophy. The goal is a more adequate definition of appropriate diagnosis and therapy for arrhythmias in order to decrease the likelihood of cardiac morbidity and mortality in this disorder.

The specific aims of the study involve an initial survey of individuals with myotonic muscular dystrophy detailing multiple factors. Non-invasive electrocardiographic testing will be done. Using this initial data and subsequent follow-up data collected yearly the cohort of patients will be followed as to arrhythmia development over a minimum of five years and likely longer with a long-term registry and evaluation of National Death Records and Ancestry.com. This project is unique in that it characterizes a non-neurologic abnormality associated with a neuromuscular disease, myotonic muscular dystrophy.


Study Type : Observational
Actual Enrollment : 448 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Registry of Arrhythmias in Myotonic Muscular Dystrophy
Study Start Date : September 1996
Actual Primary Completion Date : January 2006
Actual Study Completion Date : February 2015


Group/Cohort Intervention/treatment
Registry of Arrhythmias
Screening of individuals with myotonic muscular dystrophy to evaluate the utility of non-invasive electrocardiographic screening methods and history in predicting serious arrhythmic events.
Other: Screening
Electrocardiography Blood Test
Other Names:
  • ECG
  • Holter Monitor
  • Blood Test




Primary Outcome Measures :
  1. Evaluate incidence of arrhythmias in myotonic muscular dystrophy [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Evaluate with diagnostic non-invasive electrocardiogram (ECG) [ Time Frame: 3 Years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient Recruitment: Will take place at the 230 hospital-affiliated MDA neuromuscular clinics. Individuals with myotonic dystrophy will be identified in the MDA clinics these will be asked to participate in the study.
Criteria

Inclusion Criteria:

  1. Age 18 and over
  2. Willing to sign informed consent
  3. Have a previous diagnosis of myotonic muscular dystrophy

Exclusion Criteria:

  1. Under age 18.
  2. Unwilling to sign consent.
  3. Unwilling to commit to long-term follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622453


Locations
United States, Indiana
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Muscular Dystrophy Association
Investigators
Principal Investigator: William Groh, MD Indiana School of Medicine

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Groh, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00622453     History of Changes
Other Study ID Numbers: 9609-31
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Muscular Dystrophies
Myotonic Dystrophy
Myotonic Disorders
Death
Death, Sudden, Cardiac
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases