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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)

Primary Purpose

Aortic Stenosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NT-pro-BNP levels
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Stenosis focused on measuring aortic stenosis, prognosis, brain natriuretic peptide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

10 patients with no aortic stenosis

100 patients with asymptomatic AS

Outcomes

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)

Secondary Outcome Measures

Full Information

First Posted
December 4, 2007
Last Updated
October 23, 2012
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00567437
Brief Title
Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
Acronym
AS-BNP
Official Title
Utility of Exercise-induced NT-pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Terminated
Why Stopped
Poor patient enrollment from clinic secondary to investigator illness.
Study Start Date
December 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
aortic stenosis, prognosis, brain natriuretic peptide

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
10 patients with no aortic stenosis
Arm Title
B
Arm Type
Other
Arm Description
100 patients with asymptomatic AS
Intervention Type
Other
Intervention Name(s)
NT-pro-BNP levels
Intervention Description
pre- and post-exercise NT-pro-BNP levels
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: valvular AS (Doppler velocity ≥ 3.0 m/s) no baseline symptoms referable to valvular heart disease able to perform ETT Exclusion Criteria: more than mild aortic regurgitation, mitral regurgitation/ stenosis, or tricuspid regurgitation/stenosis previous AVR known coronary artery disease creatinine clearance 50 mL/min LVEF < 50% planned valve surgery prior to enrollment significant pulmonary disease unable to give informed consent pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M. Bashore, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John K. Harrison, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aslan T. Turer, MD
Organizational Affiliation
Duke University
Official's Role
Study Director
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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