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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
  Purpose

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


Condition
Pulmonary Artery Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identify and Characterize Populations at Risk for Developing Pulmonary Arterial Hypertension (PAH)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 140
Study Start Date: January 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581086

Contacts
Contact: Cathy J Kesssinger, RN 412-624-8330 Kessingercj@upmc.edu
Contact: Dani M Camp, RN 412-624-7403 Campdm@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Michael Risbano, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Cathy Kessinger, RN coordinator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01581086     History of Changes
Other Study ID Numbers: VAST11060550
Study First Received: April 17, 2012
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
HIV
COPD
Pulmonary disease

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014