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临床试验/NCT01714752
NCT01714752已完成不适用

Evaluation of Left Ventricular Filling Pressures During Exercise: Comparative Study, Catheterization Versus Echocardiography

French Cardiology Society2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
E/Ea ratio

研究概览

简要总结

Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures elevated only at exercise (normal at rest).

Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as a "memory" of chronic elevation of filling pressures. We believe that it is possible to improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure (LVEDP).

详细描述

Purpose Heart failure with preserved ejection fraction (HFPEF) is common and is a real public health issue. Diagnosis, especially when there are no congestive signs, is difficult. It has been shown that many patients with suspected HFPEF had left ventricular (LV) filling pressures elevated only at exercise (normal at rest).

Hypothesis Using stress echocardiography and taking into account left atrial (LA) remodeling at rest as a "memory" of chronic elevation of filling pressures. We believe that it is possible to improve the noninvasive diagnosis of exercise elevation of the LV end-diastolic pressure (LVEDP).

Methods Prospective, monocentric and comparative study: catheterization versus echocardiography.

60 patients referred for coronary angiography will be recruited consecutively during their hospitalization.

Patients should perform a low intensity and short duration exercise, in both catheterization and echo labs (pedaling 3 minutes at 25Watts then, 3 minutes at 50W) The LVEDP will be measured invasively with a pigtail, at rest and at both levels of exercise.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Patients hospitalized for coronary angiography
  • Sinus Rhythm
  • Left ventricular Ejection Fraction > 50%

排除标准

  • Age < 18years
  • Hypertrophic Cardiomyopathy
  • Cardiac transplantation
  • Mitral stenosis
  • Mitral insufficiency >2/4
  • Severe calcification of mitral annulus
  • Mitral prothesis or mitral repair
  • aortic prothesis
  • Severe aortic stenosis
  • Atrial fibrillation
  • Acute coronary syndrom < 3 months
  • Left ventricular thrombus
  • Severe renal Failure
  • failure of radial way for coronary angiography
  • coronary lesion indicating an angioplasty
  • impossibility to perform an exercise
  • refusal or inability to sign informed consent
  • no French medical insurance

结局指标

主要结局

E/Ea ratio

时间窗: Day 1

E/Ea ratio as a non-invasive index of Left Ventricular and diastolic pressure (LVEDP) at exercise

次要结局

  • left atrial (LA) morphology(Day 1)
  • LA function at rest(Day 1)
  • E/Ea ratio at exercise with LA remodeling indices at rest(Day 1)

研究者

发起方
French Cardiology Society
申办方类型
Other
责任方
Sponsor

研究点 (2)

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