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NCT Number: NCT01443598

Pulmonary Hypertension in Interstitial Lung Disease

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.

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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.

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 2 years

    Determine predictive factors of mortality

Secondary outcomes

  1. Progression-free survival (1)

    Time frame: 2 years

    Determine cause of death

  2. Progression-free survival (2)

    Time frame: 2 years

    Determine survival and time to worsening

  3. Progression-free survival (3)

    Time frame: 2 years

    Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension

  4. Progression-free survival (4)

    Time frame: 2 years

    Document the efficacy of PH specific treatment

  5. Progression-free survival (5)

    Time frame: 2 years

    Evaluate the level of pulmonary arterial hypertension and compare the functional characteristics of patients with moderate or severe pulmonary hypertension

  6. Progression-free survival (6)

    Time frame: 2 years

    Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension

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 Patients With Pre Capillary Pulmonary Hypertension

Acronym: HYPID

Important dates

Study start
2010
Primary completion
2011
Study completion
2016
First posted
Sep 29, 2011
Registry last updated
Jun 8, 2016

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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