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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karim WAHBI, Institut de Myologie, France
ClinicalTrials.gov Identifier:
NCT01136330
First received: June 2, 2010
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Myotonic Dystrophy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiac and Respiratory Prognostic Factors in Patients With Myotonic Dystrophy Type 1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut de Myologie, France:

Enrollment: 914
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.
  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

Myotonic dystrophy type 1

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136330

Locations
France
Pitié Salpêtrière Hospital
Paris, Ile de France, France, 75013
Sponsors and Collaborators
Institut de Myologie, France
Investigators
Study Director: Denis Duboc, MD,PhD APHP
  More Information

No publications provided by Institut de Myologie, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Karim WAHBI, Karim WAHBI MD,PHD., Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT01136330     History of Changes
Other Study ID Numbers: AFM-13286
Study First Received: June 2, 2010
Last Updated: February 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut de Myologie, France:
Myotonic dystrophy
Prognosis
Sudden death
Respiratory failure

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 19, 2013