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DM1 Heart Registry - DM1 Respiratory Registry (DM1-Heart-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136330
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : February 20, 2012
Information provided by (Responsible Party):
Karim WAHBI, Institut de Myologie, France

Brief Summary:

Myotonic dystrophy type 1 (DM1) is the most frequent neuromuscular disease in adults. DM1 patients have an impaired prognosis (mean age of death <60 years) due to cardiac and respiratory complications.

Our primary objective was to identify cardiac and respiratory prognostic factors in DM1.

Condition or disease
Myotonic Dystrophy

Detailed Description:
  1. Patients with genetically proven DM1 who were admitted in Pitié Salpêtrière Hospital from 2000 and 2010 will be identified. These patients systematically underwent neurological, cardiac and respiratory investigations.
  2. Baseline medical and genetic information will be entered in a dedicated database, including cardiac and respiratory investigations.
  3. The occurence of severe cardiac and respiratory adverse events will also be collected.
  4. Statistical analysis will be performed to look for correlations between baseline patient characteristics and cardiac or respiratory adverse events during follow up.

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Study Type : Observational
Actual Enrollment : 914 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiac and Respiratory Prognostic Factors in Patients With Myotonic Dystrophy Type 1
Study Start Date : May 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Myotonic dystrophy type 1

Inclusion Criteria:

  • DM1 mutation (>50 CTG repeats)
  • Age > 18 years

Exclusion Criteria:

  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136330

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Pitié Salpêtrière Hospital
Paris, Ile de France, France, 75013
Sponsors and Collaborators
Institut de Myologie, France
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Study Director: Denis Duboc, MD,PhD APHP
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Karim WAHBI, Karim WAHBI MD,PHD., Institut de Myologie, France Identifier: NCT01136330    
Other Study ID Numbers: AFM-13286
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012
Keywords provided by Karim WAHBI, Institut de Myologie, France:
Myotonic dystrophy
Sudden death
Respiratory failure
Additional relevant MeSH terms:
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Myotonic Dystrophy
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Myotonic Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn