DM1 Heart Registry - DM1 Respiratory Registry (DM1-Heart-R)
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ClinicalTrials.gov Identifier: NCT01136330 |
Recruitment Status :
Completed
First Posted : June 3, 2010
Last Update Posted : February 20, 2012
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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 |
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Myotonic Dystrophy |
- 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.
- Baseline medical and genetic information will be entered in a dedicated database, including cardiac and respiratory investigations.
- The occurence of severe cardiac and respiratory adverse events will also be collected.
- 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 |
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 |


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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 |
Inclusion Criteria:
- DM1 mutation (>50 CTG repeats)
- Age > 18 years
Exclusion Criteria:
- Patient refusal

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 ClinicalTrials.gov identifier (NCT number): NCT01136330
France | |
Pitié Salpêtrière Hospital | |
Paris, Ile de France, France, 75013 |
Study Director: | Denis Duboc, MD,PhD | APHP |
Responsible Party: | Karim WAHBI, Karim WAHBI MD,PHD., Institut de Myologie, France |
ClinicalTrials.gov 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 |
Myotonic dystrophy Prognosis Sudden death Respiratory failure |
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 |