NCT00567437

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 24, 2012

Status Verified

November 1, 2008

First QC Date

December 4, 2007

Last Update Submit

October 23, 2012

Conditions

Aortic Stenosis

Keywords

aortic stenosisprognosisbrain natriuretic peptide

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

A

OTHER

10 patients with no aortic stenosis

Other: NT-pro-BNP levels

B

OTHER

100 patients with asymptomatic AS

Other: NT-pro-BNP levels

Interventions

NT-pro-BNP levelsOTHER

pre- and post-exercise NT-pro-BNP levels

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • valvular AS (Doppler velocity ≥ 3.0 m/s)
  • no baseline symptoms referable to valvular heart disease
  • able to perform ETT

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Thomas M. Bashore, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • John K. Harrison, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Aslan T. Turer, MD

    Duke University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

December 1, 2007

Study Completion

December 1, 2008

Last Updated

October 24, 2012

Record last verified: 2008-11

Locations

US(1)