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Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis

NCT ID: NCT00567437

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Aortic Stenosis

Keywords

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aortic stenosis prognosis brain natriuretic peptide

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

10 patients with no aortic stenosis

Group Type OTHER

NT-pro-BNP levels

Intervention Type OTHER

pre- and post-exercise NT-pro-BNP levels

B

100 patients with asymptomatic AS

Group Type OTHER

NT-pro-BNP levels

Intervention Type OTHER

pre- and post-exercise NT-pro-BNP levels

Interventions

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NT-pro-BNP levels

pre- and post-exercise NT-pro-BNP levels

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. more than mild aortic regurgitation, mitral regurgitation/ stenosis, or tricuspid regurgitation/stenosis
2. previous AVR
3. known coronary artery disease
4. creatinine clearance 50 mL/min
5. LVEF \< 50%
6. planned valve surgery prior to enrollment
7. significant pulmonary disease
8. unable to give informed consent
9. pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas M. Bashore, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

John K. Harrison, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Aslan T. Turer, MD

Role: STUDY_DIRECTOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00002221

Identifier Type: -

Identifier Source: org_study_id