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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion; Sleep Apnea, Obstructive; Heart Failure

Treatments: Other: Sham CPAP treatment; Procedure: CPAP treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01900379

2013-A00543-42 (Other Identifier)

1310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups

OSA/CPAP

Experimental group

Description:

OSA patients intervention : CPAP treatment

Treatment:

Procedure: CPAP treatment

OSA/sham CPAP

Sham Comparator group

Description:

OSA patients intervention : Sham CPAP treatment

Treatment:

Other: Sham CPAP treatment

control group

No Intervention group

Description:

Patients without any apnea syndrome