Biomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH)

This study has been completed.
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00566423
First received: November 29, 2007
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post exercise.


Condition Intervention
Pulmonary Arterial Hypertension
Other: Blood draw

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Biomarkers in the Diagnosis and Assessment of PAH

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Assess the correlation of plasma/arterial BNP and MIF levels pre/post with the 6 Minute walk test distance and echocardiographic parameters as surrogate markers of severity of PAH. [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if changes in plasma/arterial MIF levels pre/post 6MW test are due to MIF released from the lungs [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: May 2007
Study Completion Date: June 2010
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with Pulmonary Arterial Hypertension
Other: Blood draw
Venous and Arterial Blood draw samples; 6 Minute Walk test

Detailed Description:

As above

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of PAH, based on currently accepted gold standard for Right Heart Catheterization.
  • Patients with mean artery pressure of greater that 25 mm Hg at rest or 30mm Hg during exercise with pulmonary capillary wedge pressure less than 18mm Hg on right heart catheterization.

Exclusion Criteria:

  • Significant left heart disease or renal insufficiency (serum creatinine > 1.5 mg%).
  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: NCT00566423

Locations
United States, New York
North Shore-Long Island Health System
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Arunabh Talwar, MD North Shore Long Island Jewish Health System
  More Information

No publications provided

Responsible Party: Arunabh Talwar MD, North Shore-Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00566423     History of Changes
Other Study ID Numbers: 07-030, NS-LIJHS IRB # 07-030
Study First Received: November 29, 2007
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
PAH
Biomarkers
MIF
BNP
6 Minute Walk (6MW)

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014