Arrhythmias in Myotonic Muscular Dystrophy
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...
Brief Summary
Official Title: “A Registry of Arrhythmias in Myotonic Muscular Dystrophy”
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.
- Study Type: Observational
- Study Design: N/A
- Study Primary Completion Date: January 2006
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Other: Screening
- Electrocardiography Blood Test
Arms, Groups and Cohorts in this Clinical Trial
- : 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.
Outcome Measures for this Clinical Trial
Primary Measures
- Evaluate incidence of arrhythmias in myotonic muscular dystrophy
- Time Frame: 3 years
Safety Issue?: No
- Time Frame: 3 years
Secondary Measures
- Evaluate with diagnostic non-invasive electrocardiogram (ECG)
- Time Frame: 3 Years
Safety Issue?: No
- Time Frame: 3 Years
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Indiana University School of Medicine Other
Overall Clinical Trial Officials and Contacts
William Groh, MD Principal Investigator Indiana School of Medicine
Related Publications
Citations Reporting Results
Groh WJ, Groh MR, Saha C, Kincaid JC, Simmons Z, Ciafaloni E, Pourmand R, Otten RF, Bhakta D, Nair GV, Marashdeh MM, Zipes DP, Pascuzzi RM. Electrocardiographic abnormalities and sudden death in myotonic dystrophy type 1. N Engl J Med. 2008 Jun 19;358(25):2688-97.
Bhakta D, Lowe MR, Groh WJ. Prevalence of structural cardiac abnormalities in patients with myotonic dystrophy type I. Am Heart J. 2004 Feb;147(2):224-7.
Hardin BA, Lowe MR, Bhakta D, Groh WJ. Heart rate variability declines with increasing age and CTG repeat length in patients with myotonic dystrophy type 1. Ann Noninvasive Electrocardiol. 2003 Jul;8(3):227-32.
Groh WJ, Lowe MR, Zipes DP. Severity of cardiac conduction involvement and arrhythmias in myotonic dystrophy type 1 correlates with age and CTG repeat length. J Cardiovasc Electrophysiol. 2002 May;13(5):444-8.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00622453
Study ID Number: 9609-31
ClinicalTrials.gov Identifier: NCT00622453
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00622453
