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Utility of Exercise-Induced NT-Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis (AS-BNP)

This study is not yet open for participant recruitment.
Verified by Duke University, December 2007

Sponsored by: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00567437
  Purpose

100 patients with moderate-severe asymptomatic 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 excercise.


Condition Intervention
Asymptomatic Aortic Stenosis
Other: NT-pro-BNP levels

MedlinePlus related topics:   Exercise and Physical Fitness   

ChemIDplus related topics:   Nesiritide    Proline   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Open Label, Parallel Assignment
Official Title:   Utility of Exercise-Induced NT-Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

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

Criteria

Inclusion Criteria:

  1. valvular AS (Doppler velocity ≥3.0m/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 50mL/min
  5. LVEF<50%
  6. planned valve surgery prior to enrollment
  7. significant pulmonary disease
  8. unable to give informed consent
  9. pregnancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567437

Contacts
Contact: Aslan T Turer, MD     919-970-3341     turer001@mc.duke.edu    
Contact: Thomas M Bashore, MD     919-684-2407     basho001@mc.duke.edu    

Locations
United States, North Carolina
Duke University Medical Center     Not yet recruiting
      Durham, North Carolina, United States, 27710
      Principal Investigator: Thomas M Bashore, MD            

Sponsors and Collaborators
Duke University

Investigators
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:   Duke University Medical Center ( Dr Thomas M. Bashore, MD )
Study ID Numbers:   Pro00002221
First Received:   December 4, 2007
Last Updated:   December 4, 2007
ClinicalTrials.gov Identifier:   NCT00567437
Health Authority:   United States: Institutional Review Board

Keywords provided by Duke University:
aortic stenosis  
prognosis  
brain natriuretic peptide  

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Pathological Conditions, Anatomical
Heart Diseases
Constriction, Pathologic
Aortic valve stenosis
Aortic Valve Stenosis
Heart Valve Diseases

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 05, 2008




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