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

Tracking Information

First Received Date ^ICMJE

December 4, 2007

Last Updated Date

November 20, 2008

Start Date ^ICMJE

December 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00567437 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Parallel Assignment

Condition ^ICMJE

Aortic Stenosis

Intervention ^ICMJE

Other: NT-pro-BNP levels

Study Arms / Comparison Groups

Other: 10 patients with no aortic stenosis
Other: 100 patients with asymptomatic AS

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

110

Estimated Completion Date

March 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

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 ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00567437

Responsible Party

Dr Thomas M. Bashore, MD, Duke University Medical Center

Study ID Numbers ^ICMJE

Pro00002221

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

Investigators ^ICMJE

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

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP