Expired Study
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Indianapolis, Indiana 46202


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

9609-31


NCT ID:

NCT00622453


Secondary ID:


Study Acronym:

DM1


Brief Title:

Arrhythmias in Myotonic Muscular Dystrophy


Official Title:

A Registry of Arrhythmias in Myotonic Muscular Dystrophy


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

448


Enrollment Type:

Actual


Overall Contact Information

Official Name:William Groh, MD
Principal Investigator
Indiana School of Medicine

Study Dates

Start Date:September 1996
Completion Date:February 2015
Completion Type:Actual
Primary Completion Date:January 2006
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 13, 2018
First Received Date:February 13, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Evaluate with diagnostic non-invasive electrocardiogram (ECG)
Time Frame:3 Years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Evaluate incidence of arrhythmias in myotonic muscular dystrophy
Time Frame:3 years
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Screening
Description:Electrocardiography Blood Test
Arm Name:Registry of Arrhythmias
Other Name:ECG

Study Arms

Study Arm Type:Other
Arm Name:Registry of Arrhythmias
Description:Screening of individuals with myotonic muscular dystrophy to evaluate the utility of non-invasive electrocardiographic screening methods and history in predicting serious arrhythmic events.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University School of Medicine
Agency Class:Other
Agency Type:Collaborator
Agency Name:Muscular Dystrophy Association

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
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.
PMID:12030525
Reference Type:Results Reference
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.
PMID:14510658
Reference Type:Results Reference
Citation: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.
PMID:14760317
Reference Type:Results Reference
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):2688-97. doi: 10.1056/NEJMoa062800.
PMID:18565861

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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