NCT00566423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

November 29, 2007

Last Update Submit

June 22, 2011

Conditions

Pulmonary Arterial Hypertension

Keywords

PAHBiomarkersMIFBNP6 Minute Walk (6MW)

Outcome Measures

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.

    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

    2 year

Study Arms (1)

1

EXPERIMENTAL

Patients with Pulmonary Arterial Hypertension

Other: Blood draw

Interventions

Blood drawOTHER

Venous and Arterial Blood draw samples; 6 Minute Walk test

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore-Long Island Health System

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Arunabh Talwar, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 3, 2007

Study Start

May 1, 2007

Primary Completion

May 1, 2008

Study Completion

June 1, 2010

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

US(1)