Clinical trial NCT01900379: PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function
Official title: Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion
Sleep Apnea, Obstructive
Keywords: Obstructive sleep apneas syndrome
Continuous positive airway pressure treatment
Heart failure
Coronary reperfusion surgery
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 17
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 obstructive sleep apnea syndrome (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG) surgery or other coronary reperfusion.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment
timeFrame: After 3 months of CPAP post-operative treatment
Secondary outcomes:
measure: Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
timeFrame: After 3 months of CPAP post-operative treatment
measure: Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
timeFrame: After 3 months of CPAP post-operative treatment
measure: Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG 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 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 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.
timeFrame: After 3 months of CPAP post-operative treatment
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: