NCT01741337

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

2.3 years

First QC Date

November 23, 2012

Last Update Submit

February 1, 2017

Conditions

Central Sleep Apneas SyndromeHeart FailureCoronary Artery Bypass Graft Surgery or Other Coronary Reperfusion

Keywords

central sleep apneas syndromeheart failureall coronary reperfusionsadaptive servo-ventilation treatment

Outcome Measures

Primary Outcomes (1)

  • Percent of ventricular function recovery (left ventricular ejection fraction) improvement conferred by an adaptive servo-ventilation post-operative treatment

    Measurement of the left ventricular ejection fraction by a cardiac ultrasonography

    after 6 months of adaptive servo-ventilation post-operative treatment

Secondary Outcomes (6)

  • 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.

    After 6 months of adaptive servo-sentilation post-operative treatment

  • Assessment of the impact of nocturnal desaturation level on the vascular atherosclerosis of mammary vessels collected during coronary artery bypass 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 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.

    After 6 months of adaptive servo-sentilation post-operative treatment

  • 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 (2)

Patients treated by ventilation

EXPERIMENTAL

Adaptive servo-ventilation post-operative treatment for 6 months

Procedure: Adaptive servo-ventilation post-operative treatment for 6 months

Patients not treated by ventilation

NO INTERVENTION

Patients not treated during 6 months by an adaptive servo-ventilation

Interventions

Adaptive servo-ventilation post-operative treatment for 6 monthsPROCEDURE
Also known as: Adaptive servo-ventilation for sleep-disorderd breathing for 6 months
Patients treated by ventilation

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38000, France

Location

Related Publications (1)

  • Vazir A, Hastings PC, Dayer M, McIntyre HF, Henein MY, Poole-Wilson PA, Cowie MR, Morrell MJ, Simonds AK. A high prevalence of sleep disordered breathing in men with mild symptomatic chronic heart failure due to left ventricular systolic dysfunction. Eur J Heart Fail. 2007 Mar;9(3):243-50. doi: 10.1016/j.ejheart.2006.08.001. Epub 2006 Oct 6.

    PMID: 17030014RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Renaud TAMISIER, MD, PhD

    University Hospital of Grenoble, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2012

First Posted

December 4, 2012

Study Start

January 29, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

FR(1)