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

This study is ongoing, but not recruiting participants.

First Received: November 29, 2007 Last Updated: February 26, 2009 History of Changes

Sponsor:	North Shore Long Island Jewish Health System
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00566423

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:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Biomarkers in the Diagnosis and Assessment of PAH

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

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 ]

Estimated Enrollment:	75
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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:	North Shore-Long Island Jewish Health System ( Arunabh Talwar MD )
Study ID Numbers:	07-030, NS-LIJHS IRB # 07-030
Study First Received:	November 29, 2007
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00566423 History of Changes
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:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 30, 2009