Skip to content

Vascular Subphenotypes of Lung Disease in HIV & COPD

Identify and Characterize Populations at Risk for Developing Pulmonary Arterial Hypertension (PAH)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01581086
Acronym
VAST
Enrollment
30
Registered
2012-04-19
Start date
2012-01-31
Completion date
2017-01-31
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Artery Hypertension

Keywords

HIV, COPD, Pulmonary disease

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) and/or 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.

Interventions

None listed

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Male/Female 18-80 years of age. * Subject has been previously enrolled in PACT/MAC/ECRC study. * Must have recent ProBNP test \>120pg/ml or abnormal echocardiogram (right ventricular systolic pressure \>or=40mmHg) without evidence of left sided heart failure.

Exclusion criteria

* Previous diagnosis of congenital heart failure. * If evidence of Left ventricular systolic or diastolic dysfunction, echo will be reviewed by the PI on a case by case basis. * Creatine clearance \<60ml/min per 1.73 m2. * Undiagnosed chest pain or myocardial infarction, stroke or cardiovascular event within 3 months. * Pregnancy. * Subjects receiving chronic anticoagulant. * Inability to complete the 6 minute walk test.

Design outcomes

Primary

MeasureTime frameDescription
elevated NT-proBNP as a biomarker3 yearsestablish a pulmonary hypertension cohort for translational investigations, to determine the utility of NT-proBNP as a biomarker of PAH

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026