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Biomarkers in the Diagnosis and Assessment of PAH

This study is currently recruiting participants.
Study NCT00566423.   Last updated on February 5, 2008.   Information provided by North Shore Long Island Jewish Health System

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Descriptive Information Fields
Brief Title  Biomarkers in the Diagnosis and Assessment of PAH
Official Title  Biomarkers in the Diagnosis and Assessment of PAH
Brief Summary

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.

Detailed Description

As above

Study Phase
Study Type  Interventional
Study Design  Diagnostic, Open Label, Single Group Assignment
Primary Outcome Measure  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 Measure  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 ]
Condition  Pulmonary Arterial Hypertension
Intervention  Other: Blood draw
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  75
Start Date  May 2007
Completion Date May 2008
Eligibility 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%).
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Arunabh Talwar, MD     516-465-5400     arunabh@nshs.edu    
Contact: Patricia J. Berkoski, MS, RRT     516-465-5427     pberkosk@nshs.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00566423
Organization ID 07-030
Secondary IDs †† NS-LIJHS IRB # 07-030
Study Sponsor  North Shore Long Island Jewish Health System
Collaborators ††
Investigators 
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 2008
First Received Date  November 29, 2007
Last Updated Date February 5, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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