Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment
研究概览
简要总结
The aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG) surgery or other coronary reperfusion.
详细描述
This clinical trial is a double-blind, randomized, placebo-controlled study.
The first objective is to evaluate the influence of continuous positive airway pressure (CPAP) treatment for OSAS on the ventricular function improvement in heart failure patients, in comparison with OSA patients treated with sham CPAP. This treatment will be instaurated just after the coronary reperfusion surgery
Secondary objectives :
- Evaluation of the effect of CPAP treatment on the endothelial function
- Evaluation of the effect of CPAP treatment on systemic inflammation
- Evaluation of the effect of CPAP treatment on oxidative stress,
- Evaluation of the effect of CPAP treatment on insulin resistance,
after the coronary reperfusion surgery, in comparison with OSA patients treated with sham CPAP and non apneic control patients, with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Coronary Artery Bypass Surgery or other coronary reperfusion
- •Heart failure patient: with altered left ventricular ejection fraction by ultrasonography (≤ 50% in 2D) or in 3D
排除标准
- •Aortic or mitral valvular replacement
- •Aortic surgery
- •Triple stimulator implanted less than 6 months ago
- •Patient already treated for a SAOS syndrome
- •Patient with a central sleep apnea syndrome
- •Patient with malignant evolutive pathology
- •Pregnant or lactating women
结局指标
主要结局
Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment
时间窗: After 3 months of CPAP post-operative treatment
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
次要结局
- Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.(Sleep disordered breathing level, 2 months before surgery)
- Assessment of CPAP effect on the systemic inflammation and oxidative stress, the insulin resistance, after the surgery in comparison with sham CPAP treated patients with heart failure and OSAS.(After 3 months of CPAP post-operative treatment)
- Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.(After 3 months of CPAP post-operative treatment)
- Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG surgery.(Sleep disordered breathing level, 2 months before surgery)
- Assessment of the impact of nocturnal desaturation level on the oxidative stress, inflammation and insulin sensitivity of the abdominal and epicardiac adipose tissue collected during surgery.(Sleep disordered breathing level, 2 months before surgery)