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NCT00566423 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

— Biomarkers  

Official title:
Biomarkers in the Diagnosis and Assessment of PAH

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00566423
Other study ID # 07-030
Secondary ID NS-LIJHS IRB # 0
Status Completed
Phase N/A
First received November 29, 2007
Last updated June 22, 2011
Start date May 2007
Est. completion date June 2010

Study information
Verified date June 2011
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Description:

As above

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date June 2010
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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%).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• Blood draw
Venous and Arterial Blood draw samples; 6 Minute Walk test

Locations
Country Name City State
United States North Shore-Long Island Health System New Hyde Park New York

Sponsors (1)
Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2 year No
Secondary To determine if changes in plasma/arterial MIF levels pre/post 6MW test are due to MIF released from the lungs 2 year No
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