Clinical trial NCT01741337: PAC-IC-SAS Pilot Study - Central Sleep Apneas Syndrome and Ventricular Function
Official title: Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Sleep Apneas Syndrome
Heart Failure
Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
Keywords: central sleep apneas syndrome
heart failure
all coronary reperfusions
adaptive servo-ventilation treatment
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment
timeFrame: after 6 months of adaptive servo-ventilation post-operative treatment
Secondary outcomes:
measure: 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.
timeFrame: After 6 months of adaptive servo-sentilation post-operative treatment
measure: Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass surgery.
timeFrame: sleep disordered breathing level, 2 months before surgery
measure: 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.
timeFrame: sleep disordered breathing level, 2 months before surgery
measure: 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.
timeFrame: After 6 months of adaptive servo-sentilation post-operative treatment
measure: Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.
timeFrame: sleep disordered breathing level, 2 months before surgery
measure: Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery.
timeFrame: sleep disordered breathing level, 2 months before surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital of Grenoble, France
name: Renaud TAMISIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.