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

Tracking Information

First Received Date ^ICMJE

November 29, 2007

Last Updated Date

February 26, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00566423 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Biomarkers in the Diagnosis and Assessment of PAH

Brief Summary

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.

Detailed Description

As above

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment

Condition ^ICMJE

Pulmonary Arterial Hypertension

Intervention ^ICMJE

Other: Blood draw

Study Arms / Comparison Groups

Experimental: Patients with Pulmonary Arterial Hypertension

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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%).

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00566423

Responsible Party

Arunabh Talwar MD, North Shore-Long Island Jewish Health System

Study ID Numbers ^ICMJE

07-030, NS-LIJHS IRB # 07-030

Study Sponsor ^ICMJE

North Shore Long Island Jewish Health System

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Arunabh Talwar, MD

North Shore Long Island Jewish Health System

Information Provided By

North Shore Long Island Jewish Health System

Verification Date

February 2009

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