Utility of Exercise-Induced N-Terminal (NT) Pro-Brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis - Full Text View

Utility of Exercise-Induced N-Terminal (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, November 2008

First Received: December 4, 2007 Last Updated: November 20, 2008 History of Changes

Sponsor:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00567437

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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Fainting

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
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:

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

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
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 Medical Center ( Dr Thomas M. Bashore, MD )
Study ID Numbers:	Pro00002221
Study First Received:	December 4, 2007
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00567437 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

aortic stenosis
prognosis
brain natriuretic peptide

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Natriuretic Peptide, Brain
Heart Diseases
Physiological Effects of Drugs
Constriction, Pathologic
Cardiovascular Agents
Pharmacologic Actions

Heart Valve Diseases
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Aortic Valve Stenosis
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on November 30, 2009