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NCT02799771 Clinical Trial

HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION

Pulmonary Arterial Hypertension Clinical Trial

— HYPID-2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02799771
Other study ID # GERMOP- 005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2013
Est. completion date February 2022

Study information
Verified date August 2022
Source Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date February 2022
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Louis Pradel Hospital (Bâtiment A4) Lyon Bron

Sponsors (2)
Lead Sponsor Collaborator
Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Determine predictive factors of mortality 2 years
Secondary Progression-free survival Time to death or 10% decline in FVC 2 years
Secondary Response to therapy Proposition of patients with 10% or more decline in PVR 2 years
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