Back to resultsBiomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH) (Biomarkers)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood draw
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Arterial Hypertension focused on measuring PAH, Biomarkers, MIF, BNP, 6 Minute Walk (6MW)
Eligibility 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%).
Sites / Locations
- North Shore-Long Island Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients with Pulmonary Arterial Hypertension
Outcomes
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.
Secondary Outcome Measures
To determine if changes in plasma/arterial MIF levels pre/post 6MW test are due to MIF released from the lungs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00566423
Brief Title
Biomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH)
Acronym
Biomarkers
Official Title
Biomarkers in the Diagnosis and Assessment of PAH
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
PAH, Biomarkers, MIF, BNP, 6 Minute Walk (6MW)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients with Pulmonary Arterial Hypertension
Intervention Type
Other
Intervention Name(s)
Blood draw
Intervention Description
Venous and Arterial Blood draw samples; 6 Minute Walk test
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arunabh Talwar, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore-Long Island Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Biomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH)
We'll reach out to this number within 24 hrs