ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis (Endoth-FPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02594059
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Other: endothelial function Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
Study Start Date : December 2012
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Pulmonary idiopathic fibrosis
Patients with pulmonary idiopathic fibrosis according to ATS/ERS 2011's criteria
Other: endothelial function
measure of reactive hyperemia-peripheral artery tone index




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

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594059


Contacts
Contact: Philippe Devillier, MD PhD 33 1 46 25 27 91 p.devillier@hopital-foch.org
Contact: Hélène Neveu, MD h.neveu@hopital-foch.org

Locations
France
Hopital Europeen Georges Pompidou, dpt of pneumology Recruiting
Paris, France, 75015
Contact: Dominique Israel-Biet, MD PhD       dominique.israel-biet@aphp.fr   
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Helene Neveu, MD       h.neveu@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02594059     History of Changes
Other Study ID Numbers: 2012/56
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by Hopital Foch:
endothelial function, idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial