NCT01900379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

3.2 years

First QC Date

July 5, 2013

Last Update Submit

February 2, 2017

Conditions

Heart FailureArteriosclerosis of Coronary Artery Bypass Graft or Other Coronary ReperfusionSleep Apnea, Obstructive

Keywords

Obstructive sleep apneas syndromeContinuous positive airway pressure treatmentHeart failureCoronary reperfusion surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    After 3 months of CPAP post-operative treatment

Secondary Outcomes (6)

  • Assessment of CPAP effect on the endothelial function, after the surgery in comparison with sham CPAP treated patient with heart failure and OSAS.

    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.

    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.

    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.

    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.

    Sleep disordered breathing level, 2 months before surgery

  • +1 more secondary outcomes

Study Arms (3)

OSA/CPAP

EXPERIMENTAL

OSA patients intervention : CPAP treatment

Procedure: CPAP treatment

OSA/sham CPAP

SHAM COMPARATOR

OSA patients intervention : Sham CPAP treatment

Other: Sham CPAP treatment

control group

NO INTERVENTION

Patients without any apnea syndrome

Interventions

CPAP treatmentPROCEDURE

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.

OSA/CPAP
Sham CPAP treatmentOTHER

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.

OSA/sham CPAP

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Heart FailureSleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Renaud TAMISIER, MD, PhD

    University Hospital of Grenoble, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 16, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

FR(1)