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

Aortic Stenosis Clinical Trial

— AS-BNP  

Official title:

Utility of Exercise-induced NT-pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00567437
• Other study ID #: Pro00002221
• Status: Terminated
• Phase: N/A
• First received: December 4, 2007
• Last updated: October 23, 2012
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2008
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• NT-pro-BNP levels
pre- and post-exercise NT-pro-BNP levels

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		one year	No