临床试验/NCT00567437

NCT00567437终止不适用

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

Duke University2 个研究点分布在 1 个国家目标入组 110 人开始时间: 2007年12月最近更新: 2012年10月24日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方: Duke University
入组人数: 110
试验地点: 2
主要终点: 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)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
干预模型: Parallel
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

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

排除标准

•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

结局指标

主要结局

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)

时间窗: one year

次要结局

未报告次要终点

研究者

发起方

Duke University

申办方类型

Other

责任方

Sponsor

研究点 (2)

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