Clinical trial NCT02799771: HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION
Official title: Observational Study of Incident Patients With Pre Capillary Pulmonary Hypertension and Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Diffuse Interstitial Lung Disease
Keywords: Pulmonary arterial hypertension
Interstitial lung disease at HRCT
Lead sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2016-06-15
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Incident patients with pre capillary pulmonary hypertension and interstitial lung disease at HRCT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 years
measure: Response to therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Louis Pradel Hospital (Bâtiment A4)
state: Bron
Study officials:
affiliation: Hospices civils de Lyon / Université Lyon I
name: Vincent COTTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: