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

February 2, 2017 updated by: University Hospital, Grenoble

Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OSA/CPAP
OSA patients intervention : CPAP treatment
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.
Sham Comparator: OSA/sham CPAP
OSA patients intervention : Sham CPAP treatment
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.
No Intervention: control group
Patients without any apnea syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of ventricular function recovery (left ventricular ejection fraction (LVEF)) improvement conferred by CPAP post-operative treatment
Time Frame: After 3 months of CPAP post-operative treatment
Measurement of the left ventricular ejection fraction by a cardiac ultrasonography
After 3 months of CPAP post-operative treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
Time Frame: After 3 months of CPAP post-operative treatment
Measurement of peripheral arterial tone
After 3 months of CPAP post-operative treatment
Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.
Time Frame: After 3 months of CPAP post-operative treatment
Measurement of pulse wave velocity
After 3 months of CPAP post-operative treatment
Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected only during CABG surgery.
Time Frame: Sleep disordered breathing level, 2 months before surgery
By immunological and histological analysis of mammary vessels
Sleep disordered breathing level, 2 months before surgery
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.
Time Frame: Sleep disordered breathing level, 2 months before surgery
Measuring inflammatory and oxidative adipose markers
Sleep disordered breathing level, 2 months before surgery
Assessment of the impact of nocturnal desaturation level on the vascular reactivity of mammary vessels collected during surgery.
Time Frame: Sleep disordered breathing level, 2 months before surgery
By immunological and histological analysis of abdominal and epicardiac adipose tissue
Sleep disordered breathing level, 2 months before surgery
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.
Time Frame: After 3 months of CPAP post-operative treatment
Measurement of inflammatory and oxidative serum markers
After 3 months of CPAP post-operative treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Renaud TAMISIER, MD, PhD, University Hospital of Grenoble, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1310
  • 2013-A00543-42 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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