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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01581086
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : June 21, 2017
Information provided by (Responsible Party):
Cathy Kessinger, University of Pittsburgh

Brief Summary:
This study is looking for high blood pressure in the lungs (Pulmonary artery hypertension PAH) in HIV and COPD patients.

Condition or disease
Pulmonary Artery Hypertension

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identify and Characterize Populations at Risk for Developing Pulmonary Arterial Hypertension (PAH)
Study Start Date : January 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : January 2017

Primary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples With DNA
Whole Blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01581086

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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Michael Risbano, MD University of Pittsburgh

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Responsible Party: Cathy Kessinger, RN coordinator, University of Pittsburgh Identifier: NCT01581086    
Other Study ID Numbers: VAST11060550
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: May 2016
Keywords provided by Cathy Kessinger, University of Pittsburgh:
Pulmonary disease
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases