Arrhythmia Clinical Trial
— DM1Official title:
A Registry of Arrhythmias in Myotonic Muscular Dystrophy
Verified date | February 2018 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 448 |
Est. completion date | February 2015 |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Krannert Institute of Cardiology | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University School of Medicine | Muscular Dystrophy Association |
United States,
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. — View Citation
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) — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate incidence of arrhythmias in myotonic muscular dystrophy | 3 years | ||
Secondary | Evaluate with diagnostic non-invasive electrocardiogram (ECG) | 3 Years |
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