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HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION (HYPID-2)

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ClinicalTrials.gov Identifier: NCT02799771
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires

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


Condition or disease
Pulmonary Arterial Hypertension Diffuse Interstitial Lung Disease

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.


Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Incident Patients With Pre Capillary Pulmonary Hypertension and Interstitial Lung Disease
Study Start Date : February 2013
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : February 2022





Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    Determine predictive factors of mortality


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Incident patients with pre capillary pulmonary hypertension and interstitial lung disease at HRCT
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799771


Locations
France
Louis Pradel Hospital (Bâtiment A4)
Lyon, Bron, France, 69677
Sponsors and Collaborators
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Hospices Civils de Lyon
Investigators
Principal Investigator: Vincent COTTIN, MD Hospices civils de Lyon / Université Lyon I

Additional Information:
Responsible Party: Vincent COTTIN, Professor Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
ClinicalTrials.gov Identifier: NCT02799771     History of Changes
Other Study ID Numbers: GERMOP- 005
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Keywords provided by Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires:
Pulmonary arterial hypertension
Interstitial lung disease at HRCT

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Lung Diseases, Interstitial
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases