Ignite Creation Date:
2024-05-06 @ 12:28 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01581086
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2012-04-17
Brief Title:
Vascular Subphenotypes of Lung Disease in HIV COPD
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Identify and Characterize Populations at Risk for Developing Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAST
Brief Summary:
This study is looking for high blood pressure in the lungs Pulmonary artery hypertension PAH in HIV and COPD patients
Detailed Description:
The goal of the project is to identify and characterize populations at risk for developing pulmonary arterial hypertension PAH The project will establish a PAH subphenotype core cohort CORE to evaluate mechanistic pathways and test novel therapeutic agents This core cohort serves as a resource for the Translational Program Project grant Vascular Subphenotypes of Lung Disease Mark Gladwin PI In order to construct the CORE we have chosen to recruit COPD and HIV patients two populations with advanced lung and systemic diseases that are enriched for PAH We have selected these as prototypic conditions because A both COPD patients and HIV-infected patients develop PAH at a rate significantly greater than the general population B morbidity and mortality are greatly increased in dually-affected persons C mechanisms responsible for development of the PAH subphenotype are not well-understood D clinical and genetic characteristics of the subgroup with PAH are not known and E effects of PAH therapies in subphenotypes are incompletely studied There is also some overlap between COPD and HIV with HIV-infected patients having accelerated COPD even with effective antiretroviral therapy Participants with COPD HIV or HIV-uninfected controls will be recruited to the study based on entry criteria of elevated N-terminal pro-brain natriuretic peptide NT-proBNP andor an abnormal echocardiogram These subjects will then undergo a 6-minute walk test blood collection questionnaire medical record review and echocardiography if not previously performed Selected subjects will then be recruited to undergo right heart catheterization The goals of the study are to establish a pulmonary hypertension cohort for translational investigations to determine the utility of NT-proBNP as a biomarker of PAH to determine clinical characteristics and relationship of lung function to PAH in COPD and HIV and to establish a biorepository for mechanistic studies of PAH phenotypes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None