Clinical trial NCT01581086: Vascular Subphenotypes of Lung Disease in HIV & COPD
Official title: Identify and Characterize Populations at Risk for Developing Pulmonary Arterial Hypertension (PAH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Artery Hypertension
Keywords: HIV
COPD
Pulmonary disease
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pitt mens Study(MACS).

University of Pittsburgh HIV Clinic(PACT).

Emphysema COPD Research Center Research Registry(ECRC).

University of Pittsburgh Medical center pulmonary hypertension clinic

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.

Eligibility criteria: 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.

Primary outcomes:
measure: elevated NT-proBNP as a biomarker
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michael Risbano, MD
role: PRINCIPAL_INVESTIGATOR
References: