Arrhythmias in Myotonic Muscular Dystrophy

Arrhythmia Clinical Trial

— DM1  

Official title:

A Registry of Arrhythmias in Myotonic Muscular Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622453
• Other study ID #: 9609-31
• Status: Completed
• Phase: N/A
• First received: February 13, 2008
• Last updated: February 13, 2018
• Start date: September 1996
• Est. completion date: February 2015

Study information

• Verified date: February 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arrhythmia
• Death
• Death, Sudden, Cardiac
• Muscular Dystrophies
• Muscular Dystrophy
• Myotonic Dystrophy
• Sudden Cardiac Death

Intervention

Other:
• Screening
Electrocardiography Blood Test

Locations

Country	Name	City	State
United States	Krannert Institute of Cardiology	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Muscular Dystrophy Association

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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