HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02799771

Acronym

HYPID-2

Enrollment

210

Registered

2016-06-15

Start date

2013-02-28

Completion date

2022-02-28

Last updated

2022-08-03

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-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.

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

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

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 years	Time to death or 10% decline in FVC
Response to therapy	2 years	Proposition of patients with 10% or more decline in PVR

Countries

France

Outcome results