Pulmonary Hypertension in Interstitial Lung Disease

Observational Study of Patients With Pre Capillary Pulmonary Hypertension

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01443598

Acronym

HYPID

Enrollment

224

Registered

2011-09-29

Start date

2010-07-31

Completion date

2016-06-30

Last updated

2016-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Interstitial Lung Disease, Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertension,, Interstitial lung disease at HRCT

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 (1)	2 years	Determine cause of death
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
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

Countries

France

Outcome results