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Pulmonary Hypertension in Interstitial Lung Disease (HYPID)

This study has been completed.
Sponsor:
Collaborator:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Vincent COTTIN, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
ClinicalTrials.gov Identifier:
NCT01443598
First received: September 28, 2011
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
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.

Condition
Pulmonary Arterial Hypertension
Diffuse Interstitial Lung Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Patients With Pre Capillary Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine predictive factors of mortality


Secondary Outcome Measures:
  • Progression-free survival (1) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine cause of death

  • Progression-free survival (2) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine survival and time to worsening

  • Progression-free survival (3) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension

  • Progression-free survival (4) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Document the efficacy of PH specific treatment

  • Progression-free survival (5) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the level of pulmonary arterial hypertension and compare the functional characteristics of patients with moderate or severe pulmonary hypertension

  • Progression-free survival (6) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Analyse clinical, functional respiratory, hemodynamic features and changing characteristics of pulmonary hypertension


Biospecimen Retention:   Samples With DNA
whole blood, serum and plasma

Enrollment: 224
Study Start Date: July 2010
Study Completion Date: June 2016
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pre capillary pulmonary hypertension and interstitial lung disease at HRCT
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443598

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 / University Lyon I
  More Information

Additional Information:
Responsible Party: Vincent COTTIN, Professor V. Cottin, Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires
ClinicalTrials.gov Identifier: NCT01443598     History of Changes
Other Study ID Numbers: GERMOP-002 
Study First Received: September 28, 2011
Last Updated: June 6, 2016
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by 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

ClinicalTrials.gov processed this record on December 09, 2016