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

Utility of Exercise-Induced 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, December 2007

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

Purpose

100 patients with moderate-severe asymptomatic 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 excercise.

Condition	Intervention
Asymptomatic Aortic Stenosis	Other: NT-pro-BNP levels

MedlinePlus related topics:

Exercise and Physical Fitness

ChemIDplus related topics:

Nesiritide Proline

U.S. FDA Resources

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

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 ≥3.0m/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 50mL/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	Not yet recruiting
	Durham, North Carolina, United States, 27710
	Principal Investigator: Thomas M Bashore, MD

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

Responsible Party:	Duke University Medical Center ( Dr Thomas M. Bashore, MD )
Study ID Numbers:	Pro00002221
First Received:	December 4, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00567437
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

aortic stenosis

prognosis

brain natriuretic peptide

Study placed in the following topic categories:

Natriuretic Peptide, Brain

Pathological Conditions, Anatomical

Heart Diseases

Constriction, Pathologic

Aortic valve stenosis

Aortic Valve Stenosis

Heart Valve Diseases

Additional relevant MeSH terms:

Natriuretic Agents

Therapeutic Uses

Physiological Effects of Drugs

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 05, 2008