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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01900379
First received: July 5, 2013
Last updated: February 2, 2017
Last verified: February 2017
  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 or other coronary reperfusion.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 or Other Coronary Reperfusion

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 ]
    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 ]
    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 ]
    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. [ Time Frame: Sleep disordered breathing level, 2 months before 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. [ Time Frame: Sleep disordered breathing level, 2 months before 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. [ Time Frame: Sleep disordered breathing level, 2 months before 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. [ Time Frame: After 3 months of CPAP post-operative treatment ]
    Measurement of inflammatory and oxidative serum markers


Enrollment: 17
Actual Study Start Date: July 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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

Locations
France
University Hospital of Grenoble
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Renaud TAMISIER, MD, PhD University Hospital of Grenoble, France
  More Information

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: February 2, 2017

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

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

ClinicalTrials.gov processed this record on February 20, 2017