|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||||||
| 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. |
||||||||||||
| Detailed Description | |||||||||||||
| Study Phase | |||||||||||||
| Study Type † | Interventional | ||||||||||||
| Study Design † | Diagnostic, Open Label, Parallel Assignment | ||||||||||||
| Primary Outcome Measure † | 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 ] [ Designated as safety issue: No ] | ||||||||||||
| Secondary Outcome Measure † | |||||||||||||
| Condition † | Aortic Stenosis | ||||||||||||
| Intervention † | Other: NT-pro-BNP levels | ||||||||||||
| MEDLINE PMIDs | |||||||||||||
| Links | |||||||||||||
| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Not yet recruiting | ||||||||||||
| Enrollment † | 110 | ||||||||||||
| Start Date † | December 2007 | ||||||||||||
| Completion Date | March 2009 | ||||||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts †† |
|
||||||||||||
| Location Countries † | United States | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00567437 | ||||||||||||
| Organization ID | Pro00002221 | ||||||||||||
| Secondary IDs †† | |||||||||||||
| Study Sponsor † | Duke University | ||||||||||||
| Collaborators †† | |||||||||||||
| Investigators † |
|
||||||||||||
| Information Provided By | Duke University | ||||||||||||
| Verification Date | November 2008 | ||||||||||||
| First Received Date † | December 4, 2007 | ||||||||||||
| Last Updated Date | November 20, 2008 | ||||||||||||