Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

Pulmonary Fibrosis Clinical Trial

— Endoth-FPI  

Official title:

Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594059
• Other study ID #: 2012/56
• Status: Completed
• Phase: N/A
• Start date: December 19, 2012
• Est. completion date: July 15, 2020

Study information

• Verified date: March 2021
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• endothelial function
measure of reactive hyperemia-peripheral artery tone index

Locations

Country	Name	City	State
France	Hopital Europeen Georges Pompidou, dpt of pneumology	Paris
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of reactive hyperemia-peripheral artery tone index		day 1
Secondary	endothelial function	measure of reactive hyperemia-peripheral artery tone index	1, 2 and 3 years
Secondary	measure of reactive hyperemia-peripheral artery tone index	measure of reactive hyperemia-peripheral artery tone index at IPF exacerbation or PAHT's occurence	3 years