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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01900379
First received: July 5, 2013
Last updated: November 28, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Heart Failure
Arteriosclerosis of Coronary Artery Bypass Graft
Sleep Apnea, Obstructive
Procedure: CPAP treatment
Other: Sham CPAP treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: After 3 months of CPAP post-operative treatment ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: After 3 months of CPAP post-operative treatment ] [ Designated as safety issue: Yes ]
    Measurement of pulse wave velocity

  • Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during surgery. [ Time Frame: Sleep disordered breathing level, 2 months before surgery ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Sleep disordered breathing level, 2 months before surgery ] [ Designated as safety issue: Yes ]
    Measuring inflammatory and oxidative adipose markers

  • 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 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: After 3 months of CPAP post-operative treatment ] [ Designated as safety issue: Yes ]
    Measurement of inflammatory and oxidative serum markers


Estimated Enrollment: 69
Study Start Date: July 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 CABG 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 CABG 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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary Artery Bypass Surgery
  • Heart failure patient: with visual LVEF <45% by echocardiogram

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900379

Contacts
Contact: Renaud TAMISIER, MD, PhD 33-476-765-516 RTamisier@chu-grenoble.fr

Locations
France
University Hospital of Grenoble Recruiting
Grenoble, France, 38000
Contact: Renaud TAMISIER, MD, PhD    33-476-765-516    RTamisier@chu-grenoble.fr   
Sub-Investigator: Sandrine LAUNOIS-ROLLINAT, MD, PhD         
Sub-Investigator: Patrick LEVY, MD, PhD         
Sub-Investigator: Jean-Louis PEPIN, MD, PhD         
Sub-Investigator: Vincent BACH, MD         
Sub-Investigator: Olivier CHAVANON, MD, PhD         
Sub-Investigator: Rachid HACINI, MD         
Sub-Investigator: Paolo PORCU, MD         
Sub-Investigator: Jean-Philippe BAGUET, MD, PhD         
Sub-Investigator: Gilles BARONE-ROCHETTE, MD         
Sub-Investigator: Carole SAUNIER, MD         
Sub-Investigator: Cécile ROCCA, MD         
Sub-Investigator: Patrice FAURE, MD, PhD         
Sub-Investigator: Françoise STANKE, PharmD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Renaud TAMISIER, MD, PhD University Hospital of Grenoble, France
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01900379     History of Changes
Other Study ID Numbers: 1310, 2013-A00543-42
Study First Received: July 5, 2013
Last Updated: November 28, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
Obstructive sleep apneas syndrome
Continuous positive airway pressure treatment
Heart failure
Coronary artery bypass graft surgery

Additional relevant MeSH terms:
Apnea
Arteriosclerosis
Heart Failure
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014