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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPAP treatment
Sham CPAP treatment
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Obstructive sleep apneas syndrome, Continuous positive airway pressure treatment, Heart failure, Coronary reperfusion surgery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital of Grenoble

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

OSA/CPAP

OSA/sham CPAP

control group

Arm Description

OSA patients intervention : CPAP treatment

OSA patients intervention : Sham CPAP treatment

Patients without any apnea syndrome

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
July 5, 2013
Last Updated
February 2, 2017
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01900379
Brief Title
PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion, Sleep Apnea, Obstructive
Keywords
Obstructive sleep apneas syndrome, Continuous positive airway pressure treatment, Heart failure, Coronary reperfusion surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSA/CPAP
Arm Type
Experimental
Arm Description
OSA patients intervention : CPAP treatment
Arm Title
OSA/sham CPAP
Arm Type
Sham Comparator
Arm Description
OSA patients intervention : Sham CPAP treatment
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients without any apnea syndrome
Intervention Type
Procedure
Intervention Name(s)
CPAP treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham CPAP treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment
Description
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
Time Frame
After 3 months of CPAP post-operative treatment
Secondary Outcome Measure Information:
Title
Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
Description
Measurement of peripheral arterial tone
Time Frame
After 3 months of CPAP post-operative treatment
Title
Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
Description
Measurement of pulse wave velocity
Time Frame
After 3 months of CPAP post-operative treatment
Title
Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG surgery.
Description
By immunological and histological analysis of mammary vessels
Time Frame
Sleep disordered breathing level, 2 months before surgery
Title
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.
Description
Measuring inflammatory and oxidative adipose markers
Time Frame
Sleep disordered breathing level, 2 months before surgery
Title
Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.
Description
By immunological and histological analysis of abdominal and epicardiac adipose tissue
Time Frame
Sleep disordered breathing level, 2 months before surgery
Title
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.
Description
Measurement of inflammatory and oxidative serum markers
Time Frame
After 3 months of CPAP post-operative treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud TAMISIER, MD, PhD
Organizational Affiliation
University Hospital of Grenoble, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

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

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