ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01741337
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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.

Condition or disease Intervention/treatment Phase
Central Sleep Apneas Syndrome Heart Failure Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion Procedure: Adaptive servo-ventilation post-operative treatment for 6 months Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion
Actual Study Start Date : January 29, 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Patients treated by ventilation
Adaptive servo-ventilation post-operative treatment for 6 months
Procedure: Adaptive servo-ventilation post-operative treatment for 6 months
Other Name: Adaptive servo-ventilation for sleep-disorderd breathing for 6 months
No Intervention: Patients not treated by ventilation
Patients not treated during 6 months by an adaptive servo-ventilation



Primary Outcome Measures :
  1. Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment [ Time Frame: after 6 months of adaptive servo-ventilation post-operative treatment ]
    Measurement of the left ventricular ejection fraction by a cardiac ultrasonography


Secondary Outcome Measures :
  1. 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. [ Time Frame: After 6 months of adaptive servo-sentilation post-operative treatment ]
    Measurement of peripheral arterial tone

  2. Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    By immunological and histological analysis of mammary vessels

  3. 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

  4. 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. [ Time Frame: After 6 months of adaptive servo-sentilation post-operative treatment ]
    Measurement of inflammatory and oxidative serum markers

  5. 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 vascular reactivity study of mammary vessels

  6. Assessment of the impact of nocturnal desaturation level on the abdominal and epicardiac adipose tissue structure collected during surgery. [ Time Frame: sleep disordered breathing level, 2 months before surgery ]
    By immunological and histological analysis of abdominal and epicardiac adipose tissue



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741337


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

Publications of Results:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01741337     History of Changes
Other Study ID Numbers: 1225
2012-A01084-39 ( Other Identifier: ANSM )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017

Keywords provided by University Hospital, Grenoble:
central sleep apneas syndrome
heart failure
all coronary reperfusions
adaptive servo-ventilation treatment

Additional relevant MeSH terms:
Syndrome
Heart Failure
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Central
Disease
Pathologic Processes
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