Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

Hopital Foch43 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pulmonary Fibrosis

Interventions

endothelial functionOTHER

measure of reactive hyperemia-peripheral artery tone index

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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) 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

Locations (2)

Hopital Europeen Georges Pompidou, dpt of pneumology

Paris, France

Hopital Foch

Suresnes, France

Outcomes

Primary Outcomes

measure of reactive hyperemia-peripheral artery tone index

Time frame: day 1

Secondary Outcomes

endothelial function

measure of reactive hyperemia-peripheral artery tone index

Time frame: 1, 2 and 3 years

measure of reactive hyperemia-peripheral artery tone index

measure of reactive hyperemia-peripheral artery tone index at IPF exacerbation or PAHT's occurence

Time frame: 3 years

Data from ClinicalTrials.gov

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