Arrhythmias in Myotonic Muscular Dystrophy (DM1)

February 13, 2018 updated by: Indiana University School of Medicine

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

448

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Krannert Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
  • Blood Test
  • Holter Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate incidence of arrhythmias in myotonic muscular dystrophy
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate with diagnostic non-invasive electrocardiogram (ECG)
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

Muscular Dystrophy Association

Investigators

  • Principal Investigator: William Groh, MD, Indiana School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1996

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9609-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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