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

Heart Failure Clinical Trial

— PAC-IC-SAOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900379
• Other study ID #: 1310
• Secondary ID: 2013-A00543-42
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: February 2, 2017
• Start date: July 2013
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Arteriosclerosis
• Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion
• Heart Failure
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• CPAP treatment
This device consists in a nasal continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/CPAP patients group.

Other:
• Sham CPAP treatment
This device consists in a sham continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/sham CPAP patients group.

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment	Measurement of the left ventricular ejection fraction by a cardiac ultrasonography	After 3 months of CPAP post-operative treatment
Secondary	Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.	Measurement of peripheral arterial tone	After 3 months of CPAP post-operative treatment
Secondary	Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.	Measurement of pulse wave velocity	After 3 months of CPAP post-operative treatment
Secondary	Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG surgery.	By immunological and histological analysis of mammary vessels	Sleep disordered breathing level, 2 months before surgery
Secondary	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.	Measuring inflammatory and oxidative adipose markers	Sleep disordered breathing level, 2 months before surgery
Secondary	Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.	By immunological and histological analysis of abdominal and epicardiac adipose tissue	Sleep disordered breathing level, 2 months before surgery
Secondary	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.	Measurement of inflammatory and oxidative serum markers	After 3 months of CPAP post-operative treatment