Pulmonary Hypertension in Interstitial Lung Disease (HYPID)

June 6, 2016 updated by: Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires

Observational Study of Patients With Pre Capillary Pulmonary Hypertension

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bron
      • Lyon, Bron, France, 69677
        • Louis Pradel Hospital (Bâtiment A4)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (1)
Time Frame: 2 years
Determine cause of death
2 years
Progression-free survival (2)
Time Frame: 2 years
Determine survival and time to worsening
2 years
Progression-free survival (3)
Time Frame: 2 years
Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension
2 years
Progression-free survival (4)
Time Frame: 2 years
Document the efficacy of PH specific treatment
2 years
Progression-free survival (5)
Time Frame: 2 years
Evaluate the level of pulmonary arterial hypertension and compare the functional characteristics of patients with moderate or severe pulmonary hypertension
2 years
Progression-free survival (6)
Time Frame: 2 years
Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERMOP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Arterial Hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe