Biomarkers in the Diagnosis and Assessment of PAH - Full Text View

Biomarkers in the Diagnosis and Assessment of PAH

This study is currently recruiting participants.
Verified by North Shore Long Island Jewish Health System, February 2008

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

Purpose

We Hypothesis that baseline plasma BNP and MIF levels are surrogate markers of clinical severity of PAH and that changes in plasma BNP and MIF levels pre and post exercise.

Condition	Intervention
Pulmonary Arterial Hypertension	Other: Blood draw

Genetics Home Reference related topics:

pulmonary arterial hypertension

MedlinePlus related topics:

High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment

Official Title:	Biomarkers in the Diagnosis and Assessment of PAH

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:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 Catherization.
Patients with mean artery pressure of greater that 25 mm Hg at rest or 30mm Hg during exercise with pulmonary cappillary wedge pressure less than 18mm Hg on right heart catherization.

Exclusion Criteria:

Significant left heart disease or renal insufficiency (serum creatnine>1.5mg%).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566423

Contacts


Contact: Arunabh Talwar, MD	516-465-5400	arunabh@nshs.edu

Contact: Patricia J. Berkoski, MS, RRT	516-465-5427	pberkosk@nshs.edu

Locations


United States, New York
	North Shore-Long Island Health System	Recruiting
	New Hyde Park, New York, United States, 11040
	Contact: Arunabh Talwar, MD 516-465-5400 arunabh@nshs.edu
	Contact: Patricia J Berkoski, MS, RRT 516-465-5427 pberkosk@nshs.edu
	Principal Investigator: Arunabh Talwar, MD

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

Responsible Party:	North Shore-Long Island Jewish Health System ( Arunabh Talwar MD )
Study ID Numbers:	07-030, NS-LIJHS IRB # 07-030
First Received:	November 29, 2007
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00566423
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)

Study placed in the following topic categories:

Idiopathic pulmonary hypertension

Respiratory Tract Diseases

Hypertension, Pulmonary

Lung Diseases

Vascular Diseases

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 08, 2008