HYPID-2: HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT02799771

Collaborator

Hospices Civils de Lyon (Other)

210

Enrollment

Location

108

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

HYPID-2 study is an extension of HYPID study (NCT01443598) :

HYPID-2 is also an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization.

It concerns only incident patients (i.e patients included within 6 months after PH diagnosis) whereas HYPID concerned prevalent and incident cases.

The primary aim is the same than HYPID : identify prognostic factors

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension Diffuse Interstitial Lung Disease

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.

As in HYPID, the main purpose of HYPID-2 is to determine predictive factors of mortality within this cohort of incident patients (i.e patients included within 6 months after PH diagnosis).

In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of incident patients.

Each incident patient will be followed during 2 years at least.

Study Design

Study Type:

Observational

Actual Enrollment :

210 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study of Incident Patients With Pre Capillary Pulmonary Hypertension and Interstitial Lung Disease

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2022

Outcome Measures

Primary Outcome Measures

Overall survival [2 years]
Determine predictive factors of mortality

Secondary Outcome Measures

Progression-free survival [2 years]
Time to death or 10% decline in FVC
Response to therapy [2 years]
Proposition of patients with 10% or more decline in PVR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients newly diagnosed with:

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 NICE 2013 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