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

Not Applicable

Completed

• Conditions: Central Sleep Apneas Syndrome; Heart Failure; Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
• Interventions: Procedure: Adaptive servo-ventilation post-operative treatment for 6 months

• Registration Number: NCT01741337
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Study Start: 2013-01-29
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients treated by ventilation	Adaptive servo-ventilation post-operative treatment for 6 months	Adaptive servo-ventilation post-operative treatment for 6 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France