PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected during surgery. Assessment of the impact of nocturnal desaturation level on the oxidative stress, inflammation and insulin sensitivity on abdominal and epicardiac adipose tissue collected during surgery.

Official Title
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Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion

Conditions
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Heart Failure, Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion, Sleep Apnea, Obstructive

Intervention / Treatment
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* Procedure: CPAP treatment
* Other: Sham CPAP treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSA/CPAP<br>OSA patients intervention : CPAP treatment | Procedure: CPAP treatment<br>* This device consists in a nasal continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/CPAP patients group.<br>|
| Sham Comparator: OSA/sham CPAP<br>OSA patients intervention : Sham CPAP treatment | Other: Sham CPAP treatment<br>* This device consists in a sham continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/sham CPAP patients group.<br>|
| No Intervention: control group<br>Patients without any apnea syndrome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment | Measurement of the left ventricular ejection fraction by a cardiac ultrasonography | After 3 months of CPAP post-operative treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS. | Measurement of peripheral arterial tone | 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. | Measurement of pulse wave velocity | 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. | By immunological and histological analysis of mammary vessels | 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. | Measuring inflammatory and oxidative adipose markers | Sleep disordered breathing level, 2 months before surgery | 
| Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery. | By immunological and histological analysis of abdominal and epicardiac adipose tissue | 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. | Measurement of inflammatory and oxidative serum markers | After 3 months of CPAP post-operative treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apneas syndrome, Continuous positive airway pressure treatment, Heart failure, Coronary reperfusion surgery