PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Heart Failure; Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion
• Interventions: Other: Sham CPAP treatment; Procedure: CPAP treatment

• Registration Number: NCT01900379
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-16
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSA/sham CPAP	Sham CPAP treatment	OSA patients intervention : Sham CPAP treatment
OSA/CPAP	CPAP treatment	OSA patients intervention : CPAP treatment

Primary Outcome Measures

Name	Time	Method
Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment	After 3 months of CPAP post-operative treatment	Measurement of the left ventricular ejection fraction by a cardiac ultrasonography

Secondary Outcome Measures

Name	Time	Method
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 immunological and histological analysis of abdominal and epicardiac adipose tissue
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.	After 3 months of CPAP post-operative treatment	Measurement of inflammatory and oxidative serum markers
Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.	After 3 months of CPAP post-operative treatment	Measurement of pulse wave velocity
Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG 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

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France