NCT01418248已完成不适用
Evaluation of Exercise Intolerance and Right Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Diagnostic Utility ExE and CPX
研究概览
简要总结
Heart Failure with Preserved Ejection Fraction (HFpEF) and Pulmonary Hypertension (PH) can be diagnosed noninvasively by Exercise Echocardiography (ExE) and Cardiopulmonary Exercise Testing (CPX) as compared with gold standard invasive hemodynamic assessment.
详细描述
- The broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance.
- The specific objective is to prospectively compare established and novel parameters derived from echocardiography and CPX with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup.
- The primary hypothesis is that combined ExE and CPX can noninvasively identify HFpEF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •exertional intolerance/dyspnea of unknown etiology
- •referral to cardiac catheterization laboratory
- •undergoing invasive hemodynamic evaluation for clinical purposes
排除标准
- •hypertrophic cardiomyopathy
- •constrictive pericarditis
- •infiltrative myopathy (e.g. amyloid)
- •congenital heart disease
- •resting LVEF <50%
- •> moderate mitral annular calcification
- •moderate or greater left-sided valvular stenosis or regurgitation
- •prior valve surgery
- •basal septal wall motion abnormalities
- •>70% epicardial coronary artery stenosis
- •right ventricular infarction
- •pregnancy
结局指标
主要结局
Diagnostic Utility ExE and CPX
时间窗: Same day as clinically indicated Right Heart Catheterization (RHCath)
次要结局
- Multiple integrated measures of cardiovascular function derived from RHCath, ExE and CPX along with rest/exercise natriuretic peptide levels(Same day as clinically indicated RHCath)
研究者
研究点 (1)
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