Assessment of Peripheral Endothelial Function in Idiopath... | NCT02594059

Studies
Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

NCT02594059

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Mar 17, 2021Actual

Enrollment

43Actual

Phase

Not Applicable

Conditions

Pulmonary Fibrosis

Interventions

endothelial function

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2012Actual

Primary Completion Date

Jul 15, 2020Actual

Completion Date

Jul 15, 2020Actual

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Oct 30, 2015

First Posted Date

Nov 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2021

Last Update Posted Date

Mar 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary idiopathic fibrosis	Experimental	Patients with pulmonary idiopathic fibrosis according to ATS/ERS 2011's criteria	Other: endothelial function

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endothelial function	Other	measure of reactive hyperemia-peripheral artery tone index	Pulmonary idiopathic fibrosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measure of reactive hyperemia-peripheral artery tone index		day 1

Secondary Outcomes

Measure	Description	Time Frame
endothelial function	measure of reactive hyperemia-peripheral artery tone index	1, 2 and 3 years
measure of reactive hyperemia-peripheral artery tone index	measure of reactive hyperemia-peripheral artery tone index at IPF exacerbation or PAHT's occurence

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Europeen Georges Pompidou, dpt of pneumology		Paris		75015	France
Hopital Foch

Condition Browse Module

MeSH Terms

ID	Term
D011658	Pulmonary Fibrosis
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided