Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

Not Applicable

Completed

• Conditions: Pulmonary Fibrosis
• Interventions: Other: endothelial function

• Registration Number: NCT02594059
• Lead Sponsor: Hopital Foch

Brief Summary

The aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF.

Detailed Description

The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the forced expiratory volume at one second (FEV1), the forced vital capacity (FVC) and the total lung capacity (TLC) and the diffusing capacity of the lung for carbon monoxide (DLCO). The dyspnea will be assessed with the New York Heart Association (NYHA) score. The exercise capacity will be assessed by the 6-min walk test. Pulmonary arterial pressure will be recorded through cardiac echography or catheterization.

Study Timeline

• Study Start: 2012-12-19
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• IPF according to ATS/ERS 2011's criteria
• Stable IPF (no reduction of FVC or DLCO of more than 10% and 15% respectively)

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Exclusion Criteria

• Patients with a significant disease other than IPF. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
• Pregnant or nursing women.
• Non-pulmonary fibrosis
• treatment by pulmonary vasodilators that cannot be stopped for 24 hours for the assessment of endothelial function

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary idiopathic fibrosis	endothelial function	Patients with pulmonary idiopathic fibrosis according to ATS/ERS 2011's criteria

Primary Outcome Measures

Name	Time	Method
measure of reactive hyperemia-peripheral artery tone index	day 1

Secondary Outcome Measures

Name	Time	Method
measure of reactive hyperemia-peripheral artery tone index	3 years	measure of reactive hyperemia-peripheral artery tone index at IPF exacerbation or PAHT's occurence
endothelial function	1, 2 and 3 years	measure of reactive hyperemia-peripheral artery tone index

Trial Locations

Locations (2)

Hopital Foch; 🇫🇷 Suresnes, France

Hopital Europeen Georges Pompidou, dpt of pneumology; 🇫🇷 Paris, France