NCT01187823

Brief Summary

The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 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

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 14, 2015

Status Verified

July 1, 2014

Enrollment Period

3 years

First QC Date

August 23, 2010

Last Update Submit

April 13, 2015

Conditions

Chronic Heart FailureSleep Apnea

Keywords

Chronic heart failureCentral sleep apneaObstructive sleep apneaAdaptive servo ventilation

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction confirmed by echocardiography

    three months

Secondary Outcomes (8)

  • Sleep quality confirmed by polysomnography

    three months

  • Endothelial function

    three months

  • Sleepiness

    three months

  • Blood pressure

    three months

  • Serum biomarkers

    three months

  • +3 more secondary outcomes

Study Arms (2)

Nocturnal oxygen therapy

ACTIVE COMPARATOR
Device: Nocturnal oxygen

Adaptive servo ventilation

ACTIVE COMPARATOR

Bipap® auto SV Advanced

Device: Adaptive servo ventilation

Interventions

Adaptive servo ventilationDEVICE

Nocturnal use of Adaptive servo ventilation

Also known as: Bipap® auto SV Advanced (Philips Respironics)
Adaptive servo ventilation
Nocturnal oxygenDEVICE

Nocturnal use of oxygen

Nocturnal oxygen therapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Left ventricular ejection fraction\<50% confirmed by echocardiography
  • Apnea hypopnea index(AHI)\>=20 confirmed by overnight polysomnography
  • More than 15% of AHI is due to CSA

You may not qualify if:

  • Changes of cardioactive drug prescriptions within 6 weeks
  • Admission due to cardiovascular events within 6 weeks
  • Ever used CPAP or ASV for sleep apnea
  • Ever used nocturnal oxgen therapy
  • Subjects with acute exacerbation of chronic heart failure
  • Operation for upper airway within 90 days
  • Renal dialysis
  • History of stroke with neurological deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Related Publications (1)

  • Murase K, Ono K, Yoneda T, Iguchi M, Yokomatsu T, Mizoguchi T, Izumi T, Akao M, Miki S, Nohara R, Ueshima K, Mishima M, Kimura T, White DP, Chin K. Adaptive servoventilation versus oxygen therapy for sleep disordered breathing in patients with heart failure: a randomised trial. Open Heart. 2016 Mar 31;3(1):e000366. doi: 10.1136/openhrt-2015-000366. eCollection 2016.

    PMID: 27099761DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, CentralSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Kazuo Chin, MD, PhD

    Kyoto University, Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

  • Takeshi Kimura, MD,PhD

    Kyoto University, Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

  • MIchiaki Mishima, MD,PhD

    Kyoto University, Graduate School of Medicine

    STUDY CHAIR

  • Kimihiko Murase, MD

    Kyoto University, Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

April 14, 2015

Record last verified: 2014-07

Locations

JP(1)