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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Cathy Kessinger, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01581086
First received: April 17, 2012
Last updated: September 4, 2014
Last verified: September 2014

April 17, 2012
September 4, 2014
January 2012
January 2016   (final data collection date for primary outcome measure)
elevated NT-proBNP as a biomarker [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

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.
 
Recruiting
140
January 2017
January 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.
Both
18 Years to 80 Years
No
Contact: Cathy J Kesssinger, RN 412-624-8330 Kessingercj@upmc.edu
Contact: Dani M Camp, RN 412-624-7403 Campdm@upmc.edu
United States
 
NCT01581086
VAST11060550
Yes
Cathy Kessinger, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Michael Risbano, MD University of Pittsburgh
University of Pittsburgh
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP