NCT02930408

Brief Summary

Steinert's disease is an orphan disease. The prognosis of patients with this disease is conditioned by cardiac involvement. Search an early stage alterations in contractile function in subjects suffering from dystrophy would detect patients at risk of sudden death. The first stage of work is to validate the tools to detect early stage of infringement systolic function in a population of patients with myotonic dystrophy.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
Last Updated

October 12, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

October 10, 2016

Last Update Submit

October 11, 2016

Conditions

Steinert's Disease

Outcome Measures

Primary Outcomes (3)

  • Ventricular Ejection Fraction Left 3D

    Immediately

  • Global longitudinal systolic Strain

    Immediately

  • Strain of the dispersion index

    Immediately

Interventions

electrocardiogramPROCEDURE
EchocardiographyPROCEDURE

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients suffering from muscular dystrophy type 1 followed CHU Poitiers.
  • age ≥ 18 years

You may not qualify if:

  • duration QRS\> 120 ms ECG permanent ventricular stimulation
  • trouble segmental kinetic obvious to echocardiography in visual analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesMyotonic DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Last Updated

October 12, 2016

Record last verified: 2016-08