Brief Title
Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
Official Title
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.
Study Type
Interventional
Primary Outcome
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)
Condition
Aortic Stenosis
Intervention
NT-pro-BNP levels
Study Arms / Comparison Groups
A
Description: 10 patients with no aortic stenosis
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
Other
Estimated Enrollment
110
Start Date
December 2007
Completion Date
December 2008
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Thomas M. Bashore, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00567437
Organization ID
Pro00002221
Responsible Party
Sponsor
Study Sponsor
Duke University
Study Sponsor
Thomas M. Bashore, MD, Principal Investigator, Duke University
Verification Date
November 2008