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Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis (AS-BNP)

This study has been terminated.
(Poor patient enrollment from clinic secondary to investigator illness.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567437
First Posted: December 5, 2007
Last Update Posted: October 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
December 4, 2007
December 5, 2007
October 24, 2012
December 2007
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00567437 on ClinicalTrials.gov Archive Site
Not Provided
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Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
Utility of Exercise-induced NT-pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
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.
Not Provided
Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Aortic Stenosis
Other: NT-pro-BNP levels
pre- and post-exercise NT-pro-BNP levels
  • A
    10 patients with no aortic stenosis
    Intervention: Other: NT-pro-BNP levels
  • B
    100 patients with asymptomatic AS
    Intervention: Other: NT-pro-BNP levels
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
110
December 2008
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00567437
Pro00002221
No
Not Provided
Not Provided
Duke University
Duke University
Not Provided
Principal Investigator: Thomas M. Bashore, MD Duke University
Principal Investigator: John K. Harrison, MD Duke University
Study Director: Aslan T. Turer, MD Duke University
Duke University
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP