Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02594059

Acronym

Endoth-FPI

Enrollment

Registered

2015-11-02

Start date

2012-12-19

Completion date

2020-07-15

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis

Keywords

endothelial function, idiopathic pulmonary fibrosis

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.

Interventions

OTHERendothelial function

measure of reactive hyperemia-peripheral artery tone index

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
measure of reactive hyperemia-peripheral artery tone index	day 1

Secondary

Measure	Time frame	Description
endothelial function	1, 2 and 3 years	measure of reactive hyperemia-peripheral artery tone index
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026