Central Sleep Apneas Syndrome, Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion, Heart Failure
Conditions
Keywords
central sleep apneas syndrome, heart failure, all coronary reperfusions, adaptive servo-ventilation treatment
Brief summary
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
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.
Interventions
PROCEDUREAdaptive servo-ventilation post-operative treatment for 6 months
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment | after 6 months of adaptive servo-ventilation post-operative treatment | Measurement of the left ventricular ejection fraction by a cardiac ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass surgery. | sleep disordered breathing level, 2 months before surgery | By immunological and histological analysis of mammary vessels |
| 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 | Measuring inflammatory and oxidative adipose markers |
| 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. | After 6 months of adaptive servo-sentilation post-operative treatment | Measurement of peripheral arterial tone |
| 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 | By vascular reactivity study of mammary vessels |
| Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery. | sleep disordered breathing level, 2 months before surgery | By immunological and histological analysis of abdominal and epicardiac adipose tissue |
| 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. | After 6 months of adaptive servo-sentilation post-operative treatment | Measurement of inflammatory and oxidative serum markers |
Countries
France
Outcome results
None listed