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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.
 
ClinicalTrials.gov Identifier: NCT01136330
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):
Karim WAHBI, Institut de Myologie, France

Tracking Information
First Submitted Date June 2, 2010
First Posted Date June 3, 2010
Last Update Posted Date February 20, 2012
Study Start Date May 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01136330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DM1 Heart Registry - DM1 Respiratory Registry
Official Title Cardiac and Respiratory Prognostic Factors in Patients With Myotonic Dystrophy Type 1
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.

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Myotonic dystrophy type 1
Condition Myotonic Dystrophy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 17, 2012)
914
Original Estimated Enrollment
 (submitted: June 2, 2010)
930
Actual Study Completion Date September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01136330
Other Study ID Numbers AFM-13286
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karim WAHBI, Institut de Myologie, France
Study Sponsor Institut de Myologie, France
Collaborators Not Provided
Investigators
Study Director: Denis Duboc, MD,PhD APHP
PRS Account Institut de Myologie, France
Verification Date February 2012