Utility of Exercise-Induced N-Terminal (NT) Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis - Tabular View

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Utility of Exercise-Induced N-Terminal (NT) Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis (AS-BNP)

This study is not yet open for participant recruitment.

Study NCT00567437. Last updated on November 20, 2008. Information provided by Duke University

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Utility of Exercise-Induced N-Terminal (NT) Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis

Official Title ^†

Utility of Exercise-Induced NT-Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis

Brief Summary

One hundred patients with moderate to severe asymptomatic aortic stenosis (AS) will be asked to exercise on a treadmill. NT-pro-BNP levels will be drawn before and after exercise. Changes in NT-pro-BNP levels will be correlated to outcomes at one year. In the pilot phase an additional 10 control subjects without AS will be enrolled to document the control response of NT-pro-BNP elevations with exercise.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Open Label, Parallel Assignment

Primary Outcome Measure ^†

development of symptomatic aortic stenosis (new/progressive angina or dyspnea, pre-syncope/syncope, hospitalization for cardiac chest pain or heart failure, drop in LV ejection fraction, cardiovascular or sudden death, valve replacement surgery) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Condition ^†

Aortic Stenosis

Intervention ^†

Other: NT-pro-BNP levels

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

110

Start Date ^†

December 2007

Completion Date

March 2009

Eligibility Criteria ^†

Inclusion Criteria:

valvular AS (Doppler velocity ≥ 3.0 m/s)
no baseline symptoms referable to valvular heart disease
able to perform ETT

Exclusion Criteria:

more than mild aortic regurgitation, mitral regurgitation/ stenosis, or tricuspid regurgitation/stenosis
previous AVR
known coronary artery disease
creatinine clearance 50 mL/min
LVEF < 50%
planned valve surgery prior to enrollment
significant pulmonary disease
unable to give informed consent
pregnancy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Aslan T. Turer, MD	919-970-3341	turer001@mc.duke.edu
Contact: Thomas M. Bashore, MD	919-684-2407	basho001@mc.duke.edu

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00567437

Organization ID

Pro00002221

Secondary IDs ^††

Study Sponsor ^†

Duke University

Collaborators ^††

Investigators ^†

Principal Investigator:	Thomas M. Bashore, MD	Duke University
Principal Investigator:	John K. Harrison, MD	Duke University
Study Director:	Aslan T. Turer, MD	Duke University

Information Provided By

Duke University

Verification Date

November 2008

First Received Date ^†

December 4, 2007

Last Updated Date

November 20, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.