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

Heart Failure Clinical Trial

Official title:

Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741337
• Other study ID #: 1225
• Secondary ID: 2012-A01084-39
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: February 1, 2017
• Start date: January 29, 2013
• Est. completion date: May 2015

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apneas Syndrome
• Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
• Heart Failure
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Syndrome

Intervention

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

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, 

References & Publications (1)

Vazir A, Hastings PC, Dayer M, McIntyre HF, Henein MY, Poole-Wilson PA, Cowie MR, Morrell MJ, Simonds AK. A high prevalence of sleep disordered breathing in men with mild symptomatic chronic heart failure due to left ventricular systolic dysfunction. Eur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment	Measurement of the left ventricular ejection fraction by a cardiac ultrasonography	after 6 months of adaptive servo-ventilation post-operative treatment
Secondary	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.	Measurement of peripheral arterial tone	After 6 months of adaptive servo-sentilation post-operative treatment
Secondary	Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass 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 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.	Measurement of inflammatory and oxidative serum markers	After 6 months of adaptive servo-sentilation post-operative treatment
Secondary	Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.	By vascular reactivity study of mammary vessels	sleep disordered breathing level, 2 months before surgery
Secondary	Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery.	By immunological and histological analysis of abdominal and epicardiac adipose tissue	sleep disordered breathing level, 2 months before surgery