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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | December 4, 2007 | ||||||||||||
| Last Updated Date | November 20, 2008 | ||||||||||||
| Start Date ICMJE | December 2007 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00567437 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Utility of Exercise-Induced N-Terminal (NT) Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis | ||||||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | |||||||||||||
| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Diagnostic, Open Label, Parallel Assignment | ||||||||||||
| Condition ICMJE | Aortic Stenosis | ||||||||||||
| Intervention ICMJE | Other: NT-pro-BNP levels | ||||||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 110 | ||||||||||||
| Estimated Completion Date | March 2009 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00567437 | ||||||||||||
| Responsible Party | Dr Thomas M. Bashore, MD, Duke University Medical Center | ||||||||||||
| Study ID Numbers ICMJE | Pro00002221 | ||||||||||||
| Study Sponsor ICMJE | Duke University | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||||||||||
| Verification Date | November 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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