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NCT Number: NCT02799771

HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION

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

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Key information

Conditions

Pulmonary Arterial Hypertension Diffuse Interstitial Lung Disease Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Louis Pradel Hospital (Bâtiment A4)

Lyon, Bron, 69677, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 2 years

    Determine predictive factors of mortality

Secondary outcomes

  1. Progression-free survival

    Time frame: 2 years

    Time to death or 10% decline in FVC

  2. Response to therapy

    Time frame: 2 years

    Proposition of patients with 10% or more decline in PVR

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

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

Acronym: HYPID-2

Important dates

Study start
2013
Primary completion
2018
Study completion
2022
First posted
Jun 15, 2016
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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