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Arrhythmias in Myotonic Muscular Dystrophy (DM1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Indiana University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00622453
First received: February 13, 2008
Last updated: March 29, 2011
Last verified: October 2010
  Purpose

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 Intervention
Muscular Dystrophy
Arrhythmia
Sudden Cardiac Death
Other: Screening

Study Type: Observational
Official Title: A Registry of Arrhythmias in Myotonic Muscular Dystrophy

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Evaluate incidence of arrhythmias in myotonic muscular dystrophy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate with diagnostic non-invasive electrocardiogram (ECG) [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Enrollment: 448
Study Start Date: September 1996
Estimated Study Completion Date: December 2012
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: February 13, 2008
Last Updated: March 29, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014