Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
Not Applicable
Terminated
- Conditions
- Aortic Stenosis
- Registration Number
- NCT00567437
- Lead Sponsor
- Duke University
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 110
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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) one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Duke University Medical Center🇺🇸Durham, North Carolina, United States