Diastolic Function in Myotonic Dystrophy Type 1

September 7, 2023 updated by: Abdallah FAYSSOIL, Centre d'Investigation Clinique et Technologique 805

Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction disorders. Mortality are mainly related to respiratory failure and sudden death. Patients with DM1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea. These comorbidities are classically associated with left ventricular diastolic dysfunction (DD) .

The investigators aim to assess the prevalence of left ventricular diastolic dysfunction in patients with myotonic dystrophy type 1 , the distribution of DD grading as well as the long-term prognosis of DM1 patients with a left ventricular diastolic dysfunction.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Garches, France, 92380
        • Recruiting
        • Hôpital Raymond Poincaré
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients with myotonic dystrophy type 1 followed in a tertiary reference center.

Description

Inclusion Criteria:

  • patients with genetic proven myotonic dystrophy type 1
  • who experienced a Doppler- Echocardiography including an assessment of the left ventricular diastolic function

Exclusion Criteria:

  • wall motion basal abnormalities
  • significant valvular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 7 years
7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of arrhythmia
Time Frame: 7 years
7 years
acute heart failure
Time Frame: 7 years
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: Abdallah FAYSSOIL, MD PhD, CHU Raymond Poincare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2023

Primary Completion (Estimated)

October 2, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECHO-DM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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