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

Duke University110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

110

Conditions

Aortic Stenosis

Interventions

NT-pro-BNP levelsOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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