PAC-IC-SAS Pilot Study - Central Sleep Apneas 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 an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following coronary artery bypass graft surgery or other coronary reperfusion.

Detailed Description
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This clinical trial is a pilot study, on patients with central sleep apneas syndrome and heart failure, undergoing coronary artery bypass graft surgery or other coronary reperfusion, and then randomized for the adaptive servo-ventilation treatment application or not after surgery. The first objective is to evaluate the effect of an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient, in terms of ventricular recovery (ejection fraction improvement). This treatment will be instaurated just after coronary artery bypass graft surgery or other coronary reperfusion. Secondary objectives : Assessment of adaptive servo-ventilation effect on the endothelial function, the systemic inflammation and oxidative stress, the insulin resistance, after the surgery in comparison with non treated patient with heart failure and central sleep apneas. Assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected only during coronary artery bypass graft 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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Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion

Conditions
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Central Sleep Apneas Syndrome, Heart Failure, Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion

Intervention / Treatment
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* Procedure: Adaptive servo-ventilation post-operative treatment for 6 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary artery bypass graft surgery or other coronary reperfusion heart failure patient: with altered left ventricular ejection fraction by ultrasonography (45%< LVEF ≤ 50% in 2D) or in 3D Patient with central sleep apneas syndrome (SAS) Exclusion Criteria: Aortic or mitral valvular surgery Patient already treated for a central SAS Patient with an obstructive SAS 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated by ventilation<br>Adaptive servo-ventilation post-operative treatment for 6 months | Procedure: Adaptive servo-ventilation post-operative treatment for 6 months<br> <br> * Other names: Adaptive servo-ventilation for sleep-disorderd breathing for 6 months;|
| No Intervention: Patients not treated by ventilation<br>Patients not treated during 6 months by an adaptive servo-ventilation | |

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) improvement conferred by an adaptive servo-ventilation post-operative treatment | Measurement of the left ventricular ejection fraction by a cardiac ultrasonography | after 6 months of adaptive servo-ventilation post-operative treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adaptive servo-ventilation effect on the endothelial function, after the surgery in comparison with non treated patient with heart failure and central sleep apneas. | Measurement of peripheral arterial tone | After 6 months of adaptive servo-sentilation post-operative treatment | 
| Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass 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 adaptive servo-ventilation effect on the systemic inflammation and oxidative stress, the insulin resistance, after the surgery in comparison with non treated patient with heart failure and central sleep apneas. | Measurement of inflammatory and oxidative serum markers | After 6 months of adaptive servo-sentilation post-operative treatment | 
| Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery. | By vascular reactivity study of mammary vessels | sleep disordered breathing level, 2 months before surgery | 
| Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery. | By immunological and histological analysis of abdominal and epicardiac adipose tissue | sleep disordered breathing level, 2 months before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central sleep apneas syndrome, heart failure, all coronary reperfusions, adaptive servo-ventilation treatment