Overview

This trial is active, not recruiting.

Conditions muscular dystrophy, arrhythmia, sudden cardiac death
Treatment screening
Sponsor Indiana University School of Medicine
Collaborator Muscular Dystrophy Association
Start date September 1996
End date January 2006
Trial size 448 participants
Trial identifier NCT00622453, 9609-31

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Evaluate incidence of arrhythmias in myotonic muscular dystrophy
time frame: 3 years

Secondary Outcomes

Measure
Evaluate with diagnostic non-invasive electrocardiogram (ECG)
time frame: 3 Years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Registry of Arrhythmias in Myotonic Muscular Dystrophy
Principal investigator William Groh, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Indiana University.