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Vascular Subphenotypes of Lung Disease in HIV & COPD (VAST)

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ClinicalTrials.gov Identifier: NCT01581086
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : June 21, 2017
Information provided by (Responsible Party):

April 17, 2012
April 19, 2012
June 21, 2017
January 2012
May 2016   (Final data collection date for primary outcome measure)
elevated NT-proBNP as a biomarker [ Time Frame: 3 years ]
establish a pulmonary hypertension cohort for translational investigations, to determine the utility of NT-proBNP as a biomarker of PAH
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Complete list of historical versions of study NCT01581086 on ClinicalTrials.gov Archive Site
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Vascular Subphenotypes of Lung Disease in HIV & COPD
Identify and Characterize Populations at Risk for Developing Pulmonary Arterial Hypertension (PAH)
This study is looking for high blood pressure in the lungs (Pulmonary artery hypertension PAH) in HIV and COPD patients.
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.
Observational Model: Cohort
Time Perspective: Retrospective
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Retention:   Samples With DNA
Whole Blood
Non-Probability Sample

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

Pulmonary Artery Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2017
May 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Cathy Kessinger, University of Pittsburgh
University of Pittsburgh
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Principal Investigator: Michael Risbano, MD University of Pittsburgh
University of Pittsburgh
May 2016