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

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ClinicalTrials.gov Identifier: NCT00566423
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Northwell Health

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Other: Blood draw Not Applicable

Detailed Description:
As above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biomarkers in the Diagnosis and Assessment of PAH
Study Start Date : May 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2010


Arm Intervention/treatment
Experimental: 1
Patients with Pulmonary Arterial Hypertension
Other: Blood draw
Venous and Arterial Blood draw samples; 6 Minute Walk test




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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%).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566423


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

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
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Northwell Health:
PAH
Biomarkers
MIF
BNP
6 Minute Walk (6MW)

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