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:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00567437
First received: December 4, 2007
Last updated: October 23, 2012
Last verified: November 2008

December 4, 2007
October 23, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00567437 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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: 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567437
Pro00002221
No
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