Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

NCT ID: NCT02594059

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-19
• Study Completion Date: 2020-07-15

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.

Conditions

Pulmonary Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pulmonary idiopathic fibrosis

Patients with pulmonary idiopathic fibrosis according to ATS/ERS 2011's criteria

Group Type: EXPERIMENTAL

endothelial function

Intervention Type: OTHER

measure of reactive hyperemia-peripheral artery tone index

Interventions

endothelial function

measure of reactive hyperemia-peripheral artery tone index

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Europeen Georges Pompidou, dpt of pneumology

Paris, , France

Hopital Foch

Suresnes, , France

Countries

France

Other Identifiers

2012/56

Identifier Type: -

Identifier Source: org_study_id