Pulmonary Hypertension in Interstitial Lung Disease

Completed

• Conditions: Diffuse Interstitial Lung Disease; Pulmonary Arterial Hypertension

• Registration Number: NCT01443598
• Lead Sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Primary Completion: 2011-12
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years	Determine predictive factors of mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Louis Pradel Hospital (Bâtiment A4); 🇫🇷 Lyon, Bron, France