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临床试验/NCT00455611
NCT00455611撤回不适用

Evaluation of the Effects of Intra-thoracic Positive Pressure Applicated With CPAP (Continuous Positive Airway Pressure) on Ventricular Function in Patients With Chronic Heart Failure: Modification Induced on Baroreflex Sensitivity

Ospedale S. Giovanni Bosco2 个研究点 分布在 1 个国家开始时间: 2006年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration

研究概览

简要总结

To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway Pressure).

详细描述

There are still few studies on the effects of positive intra-thoracic pressure on ventricular function and spontaneous baroreflex sensitivity changes. Aim of the study is to evaluate, in patients with chronic heart failure with an ejection fraction < 40%, the modifications of ventricular function induced by CPAP (Continuos Positive Airway Pressure) application. All the measurament will be made in basal condition (without CPAP) and with CPAP administration at 10 cmH2O via an oro-nasal mask.

Echocardiograpich evaluation: morphologic and hemodynamic evaluation is obtained with an echocardiographic exmination. Left ventricular measurement will be assessed in M-mode, under two dimensional guide) according to American Society of Echocardiography guidelines. Left ventricular ejection fraction will be assessed with Simpson method.

Right ventricle morphology will be evaluated categorizing dimensions in a) normal, b) mild enlargement, c) severely increased and d) reduced. Right ventricle area will also be quantified in tele-diastole and in meso-sistole in apical 4 chamber and parasternal short-axis.

Baroreflex control of heart rate was assessed by "sequence method" analysis of continuous blood pressure recordings obtained in basal condition and during CPAP. Data obtained by non invasive assessment of arterial pressure will be analized and values of arterial systolic, diastolic pressure and pulsatory period for each cardiac cicle will be registered.

Assessment via "sequence method" is founded on identification, every 10 minutes, on sequences characterized by a progressive increase both in pressure both in RR interval or, conversely, by a progressive reduction of pressure and RR interval evaluated on 4 or more cardiac cicles.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of heart failure
  • Chronic heart failure
  • Ejection fraction < 40%

排除标准

  • Age < 18 years
  • Permanent atrial fibrillation
  • Infiltrative cardiomyopathy
  • Mild/moderate chronic obstructive lung disease
  • Chronic heart failure
  • Diabetes mellitus
  • Chronic kidney failure

结局指标

主要结局

Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration

次要结局

未报告次要终点

研究者

发起方
Ospedale S. Giovanni Bosco
申办方类型
Other

研究点 (2)

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Effects of CPAP on Ventricular Function Modifications | 临床试验