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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)

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Duke University

Status

Terminated

Conditions

Aortic Stenosis

Treatments

Other: NT-pro-BNP levels

Study type

Interventional

Funder types

Other

Identifiers

NCT00567437
Pro00002221

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

A
Other group
Description:
10 patients with no aortic stenosis
Treatment:
Other: NT-pro-BNP levels
B
Other group
Description:
100 patients with asymptomatic AS
Treatment:
Other: NT-pro-BNP levels

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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