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| Sponsor: | Duke University |
|---|---|
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00567437 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Aortic Stenosis |
Other: NT-pro-BNP levels |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Utility of Exercise-Induced NT-Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis |
| Estimated Enrollment: | 110 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | March 2009 |
| Arms | Assigned Interventions |
|---|---|
|
A
10 patients with no aortic stenosis
|
Other: NT-pro-BNP levels
pre- and post-exercise NT-pro-BNP levels
|
|
B
100 patients with asymptomatic AS
|
Other: NT-pro-BNP levels
pre- and post-exercise NT-pro-BNP levels
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Aslan T. Turer, MD | 919-970-3341 | turer001@mc.duke.edu |
| Contact: Thomas M. Bashore, MD | 919-684-2407 | basho001@mc.duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Thomas M. Bashore, MD | |
| Principal Investigator: | Thomas M. Bashore, MD | Duke University |
| Principal Investigator: | John K. Harrison, MD | Duke University |
| Study Director: | Aslan T. Turer, MD | Duke University |
More Information
| Responsible Party: | Dr Thomas M. Bashore, MD, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00567437 History of Changes |
| Other Study ID Numbers: | Pro00002221 |
| Study First Received: | December 4, 2007 |
| Last Updated: | November 20, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
aortic stenosis prognosis brain natriuretic peptide |
|
Aortic Valve Stenosis Constriction, Pathologic Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Pathological Conditions, Anatomical |
Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |