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NCT01443598 Clinical Trial

Pulmonary Hypertension in Interstitial Lung Disease

Pulmonary Arterial Hypertension Clinical Trial

— HYPID  

Official title:
Observational Study of Patients With Pre Capillary Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01443598
Other study ID # GERMOP-002
Secondary ID
Status Completed
Phase N/A
First received September 28, 2011
Last updated June 6, 2016
Start date July 2010
Est. completion date June 2016

Study information
Verified date June 2016
Source Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

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.

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 224
Est. completion date June 2016
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

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 No
Secondary Progression-free survival (1) Determine cause of death 2 years No
Secondary Progression-free survival (2) Determine survival and time to worsening 2 years No
Secondary Progression-free survival (3) Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension 2 years No
Secondary Progression-free survival (4) Document the efficacy of PH specific treatment 2 years No
Secondary Progression-free survival (5) Evaluate the level of pulmonary arterial hypertension and compare the functional characteristics of patients with moderate or severe pulmonary hypertension 2 years No
Secondary Progression-free survival (6) Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension 2 years No
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