Status:

COMPLETED

Muscular Respiratory Involvement and Systemic Sclerosis

Lead Sponsor:

Poitiers University Hospital

Conditions:

Systemic Sclerosis

Diaphragm Defect

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability. Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting...

Eligibility Criteria

Inclusion

  • Age ≥18 years-old
  • ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital
  • Written informatory consent

Exclusion

  • Individuals under tutorship or guardianship
  • Individuals with reinforced protection: minors, judiciary or administrative decision
  • No affiliation to social insurance
  • Pregnancy or breastfeeding
  • Associated neuromuscular disease (myasthenia, degenerative diseases)
  • Bedridden individuals or with health condition not allowing realization or interpretation of PFT and/or EMG (acute cardiac and/or respiratory failure, pneumopathy)
  • Individuals with pacemaker and implanted pumps, especially sensing dispositives, as defibrillators ( relative contre-indication to EMG with magnetic stimulation)
  • Individuals with contre-indication to gastroesophageal probe: INR \>4, oesophageal varices, suspected cardio-facial fracture, oesophageal and/or facial obstacle

Key Trial Info

Start Date :

October 21 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 7 2021

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT04118725

Start Date

October 21 2019

End Date

July 7 2021

Last Update

September 29 2021

Active Locations (1)

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1

Chu de Poitiers

Poitiers, France