Biomarkers in the Evaluation of Chronic Lung Disease

Pulmonary Hypertension Clinical Trial

Official title:

Biomarkers in the Evaluation of Chronic Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926523
• Other study ID #: GCRC 0274
• Status: Completed
• Phase: N/A
• First received: June 19, 2009
• Last updated: May 26, 2011
• Start date: June 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage migration inhibitory factor (MIF), that remodeling is in fact the reflection of a chronic inflammatory process, and that MIF may be a useful biomarker of the severity and progression of both ILD and PH.

Description:

We hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage migration inhibitory factor (MIF), that remodeling is in fact the reflection of a chronic inflammatory process, and that MIF may be a useful biomarker of the severity and progression of both ILD and PH.

To study this hypothesis, we have two specific aims:

1. To evaluate plasma MIF concentration as a marker of severity in ILD and PH and

2. To determine the utility of breathe condensate analysis in the evaluation of ILD and PH. If we are successful in identifying MIF as a biomarker, it may identify MIF as a useful therapeutic target, as we have shown in other inflammatory disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject are at least 18 years of age

• Subject has confirmed Pulmonary Hypertension and Interstitial Lung Disease

• Subject are able to complete study procedures, such as spirometry, and Pulmonary Exercise test.

Exclusion Criteria:

• Subject are pregnant

• Subject is unable to perform tasks associated with study

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Intervention

Other:
• Blood Gas
Subject will have both venous and arterial blood draws to assess for the bloods content of MIF
• Pulmonary Exercise Test
Subject will ride exercise bike to assess their pulmonary function level.
• Spirometry
To assess subjects lung function
• Breath Condensate Collector
Subject with use breathing apparatus to allow researchers to collect breath condensate to assess level of MIF in breathe condensate.

Locations

Country	Name	City	State
United States	Interstitial Lung Disease and Pulmonary Hypertension Programs	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States,