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CompletedNCT00566423BiomarkersUpdated Jun 23, 2011

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

An interventional study of Blood draw in Pulmonary Arterial Hypertension, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-06-23.

Sponsored by Northwell Health · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

As above

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • PAH
  • Biomarkers
  • MIF
  • BNP
  • 6 Minute Walk (6MW)
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 75 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.

Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Significant left heart disease or renal insufficiency (serum creatinine > 1.5 mg%).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    1

    Patients with Pulmonary Arterial Hypertension

    Other: Blood draw

Interventions

  • OtherBlood draw

    Venous and Arterial Blood draw samples; 6 Minute Walk test

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • North Shore-Long Island Health System
    New Hyde Park, New York 11040, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00566423
Lead sponsor
Northwell Health
First posted
Dec 3, 2007
Start date
May 2007
Primary completion
May 2008
Completion
Jun 2010
Last update
Jun 23, 2011

Study contacts

Arunabh Talwar, MD
principal investigator · Northwell Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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