Pulmonary Hypertension in Interstitial Lung Disease | NCT01443598

Studies
Pulmonary Hypertension in Interstitial Lung Disease

NCT01443598

Sponsor

Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires

Status

Completed

Last Update Posted

Jun 8, 2016Estimated

Enrollment

224Actual

Phase

Not provided

Conditions

Pulmonary Arterial Hypertension
Diffuse Interstitial Lung Disease

Interventions

Not provided

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

Jun 2016

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

Jul 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Jun 2016Actual

First Submitted Date

Sep 28, 2011

First Submission Date that Met QC Criteria

Sep 28, 2011

First Posted Date

Sep 29, 2011Estimated

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

Jun 6, 2016

Last Update Posted Date

Jun 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vincent COTTIN, Professor V. Cottin, Groupe d'Etudes et de Recherche sur les Maladies Orphelines PulmonairesPrincipal Investigator

Lead Sponsor

Groupe d'Etudes et de Recherche sur les Maladies Orphelines PulmonairesOTHER

Collaborators

Name	Class
Hospices Civils de Lyon	OTHER

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

HYPID study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. The primary aim of the study is to identify prognostic factors.

Detailed Description

Pre capillary pulmonary hypertension (PH) may be present in patients with diffuse interstitial lung disease.

In this context, PH represents an important factor of morbidity and mortality for these patients.

One of the purposes of HYPID is to determine predictive factors of mortality within this cohort of patients.

In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of patients. Each patient will be followed during 2 years at least.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

224Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Determine predictive factors of mortality	2 years

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival (1)	Determine cause of death	2 years
Progression-free survival (2)	Determine survival and time to worsening

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pre capillary pulmonary hypertension at right heart sided catheterization with: mPAP > or = 25 mmHg,PCWP < or = 15 mmHg
interstitial lung disease with diffuse infiltrative opacities on chest CT scan

Exclusion Criteria:

pulmonary hypertension related to a thromboembolic disease
respiratory disease other than diffuse interstitial lung disease
any etiological factor of pulmonary arterial hypertension based on DANA POINT classification other than diffuse interstitial lung disease
any progressive disease associated to a life expectancy less than 6 months other than pulmonary hypertension, diffuse interstitial lung disease and respiratory insufficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with pre capillary pulmonary hypertension and interstitial lung disease at HRCT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent Cottin, MD	Hospices Civils de Lyon / University Lyon I	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Louis Pradel Hospital (Bâtiment A4)		Lyon	Bron	69677	France

References Module

Citations

Not provided

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases