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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Central Sleep Apneas Syndrome; Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion; Heart Failure

Treatments: Procedure: Adaptive servo-ventilation post-operative treatment for 6 months

Study type: Interventional

Funder types: Other

Identifiers

NCT01741337

2012-A01084-39 (Other Identifier)

1225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Patients treated by ventilation

Experimental group

Description:

Adaptive servo-ventilation post-operative treatment for 6 months

Treatment:

Procedure: Adaptive servo-ventilation post-operative treatment for 6 months

Patients not treated by ventilation

No Intervention group

Description:

Patients not treated during 6 months by an adaptive servo-ventilation