PAC-IC-SAS Pilot Study - Central Sleep Apneas Syndrome and Ventricular Function

Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion

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.

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.

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

central sleep apneas syndrome, heart failure, all coronary reperfusions, adaptive servo-ventilation treatment

Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment

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.

Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass 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.

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.

Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.

Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery.

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

Vazir A, Hastings PC, Dayer M, McIntyre HF, Henein MY, Poole-Wilson PA, Cowie MR, Morrell MJ, Simonds AK. A high prevalence of sleep disordered breathing in men with mild symptomatic chronic heart failure due to left ventricular systolic dysfunction. Eur J Heart Fail. 2007 Mar;9(3):243-50. doi: 10.1016/j.ejheart.2006.08.001. Epub 2006 Oct 6.