Biomarkers in the Diagnosis and Assessment of Pulmonary A... | NCT00566423

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

NCT00566423

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

75Actual

Phase

Not Applicable

Conditions

Pulmonary Arterial Hypertension

Interventions

Blood draw

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NS-LIJHS IRB # 07-030

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2008Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 29, 2007

First Submission Date that Met QC Criteria

Nov 30, 2007

First Posted Date

Dec 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Patients with Pulmonary Arterial Hypertension	Other: Blood draw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Other	Venous and Arterial Blood draw samples; 6 Minute Walk test	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To determine if changes in plasma/arterial MIF levels pre/post 6MW test are due to MIF released from the lungs		2 year

Other Outcomes

Not provided

Eligibility Module

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%).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arunabh Talwar, MD	Northwell Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Shore-Long Island Health System		New Hyde Park	New York	11040	United States

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided