Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT02594059
• Date of registration: 29/10/2015
• Prospective Registration: No
• Primary sponsor: Hopital Foch
• Public title: Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis Endoth-FPI
• Scientific title: Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
• Date of first enrolment: December 19, 2012
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02594059
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Fibrosis

Intervention(s)

Other: endothelial function

Primary Outcome(s)

measure of reactive hyperemia-peripheral artery tone index [Time Frame: day 1]

Secondary Outcome(s)

measure of reactive hyperemia-peripheral artery tone index [Time Frame: 3 years]

endothelial function [Time Frame: 1, 2 and 3 years]

Secondary ID(s)

2012/56

Source(s) of Monetary Support

Please refer to primary and secondary sponsors