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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:
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
History of Changes
  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

Resource links provided by NLM:

Drug Information available for: Nesiritide
U.S. FDA Resources

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
Study Completion Date: December 2008
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 ≥ 3.0 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567437

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00567437     History of Changes
Other Study ID Numbers: Pro00002221
Study First Received: December 4, 2007
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 23, 2013