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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Myotonic Dystrophy

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