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NCT06029192 Clinical Trial

Diastolic Function in Myotonic Dystrophy Type 1

Diastolic Dysfunction Clinical Trial

Official title:
Diastolic Function in Myotonic Dystrophy Type 1

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06029192
Other study ID # ECHO-DM1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2, 2023
Est. completion date November 1, 2023

Study information
Verified date September 2023
Source Centre d'Investigation Clinique et Technologique 805
Contact Abdallah FAYSSOIL, MD PhD
Phone +33147107778
Email abdallah.fayssoil@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date November 1, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Hopital Raymond Poincare Garches

Sponsors (1)
Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality 7 years
Secondary Incidence of arrhythmia 7 years
Secondary acute heart failure 7 years
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