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Completed

NCT Number: NCT02594059

Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

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.

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Key information

Conditions

Pulmonary Fibrosis Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Europeen Georges Pompidou, dpt of pneumology, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endothelial function

Other

measure of reactive hyperemia-peripheral artery tone index

Primary outcomes

  1. measure of reactive hyperemia-peripheral artery tone index

    Time frame: day 1

Secondary outcomes

  1. endothelial function

    Time frame: 1, 2 and 3 years

    measure of reactive hyperemia-peripheral artery tone index

  2. measure of reactive hyperemia-peripheral artery tone index

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: Endoth-FPI

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2015
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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