UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004099
Receipt number R000004923
Scientific Title Comparison of Adaptive Servo Ventilation(Bipap Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea.
Date of disclosure of the study information 2010/09/15
Last modified on 2014/07/30 20:53:28

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Basic information

Public title

Comparison of Adaptive Servo Ventilation(Bipap Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea.

Acronym

The Effect of Adaptive Servo Ventilation and Oxygen Therapy in Central Sleep Apnea Patients

Scientific Title

Comparison of Adaptive Servo Ventilation(Bipap Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea.

Scientific Title:Acronym

The Effect of Adaptive Servo Ventilation and Oxygen Therapy in Central Sleep Apnea Patients

Region

Japan


Condition

Condition

Chronic Heart Failure
Sleep Apnea

Classification by specialty

Cardiology Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Left ventricular ejection fraction confirmed by echocardiography

Key secondary outcomes

Sleep quality
Endothelial function
Sleepiness and health-related QOL
Clinical measurements
Serum and urinary biomarkers


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Adaptive servo ventilation
(Bipap auto SV Advanced)

Interventions/Control_2

Nocturnal oxygen therapy

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

1.Changes of cardioactive drug prescriptions within 6 weeks
2.Admission due to cardiovascular events within 6 weeks
3.Ever used CPAP or ASV for sleep apnea
4.Ever used nocturnal oxgen therapy
5.Subjects with acute exacerbation of chronic heart failure
6.Operation for upper airway within 90 days

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michiaki Mishima

Organization

Kyoto University, Graduate School of Medicine

Division name

Respiratory Medicine

Zip code


Address

54 Shogoin-Kawaracho Sakyo Kyoto

TEL

81-75-751-3852

Email

mishima@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Chin

Organization

Kyoto University, Graduate School of Medicine

Division name

Respiratory Care and Sleep Control Medicine

Zip code


Address

54 Shogoin-Kawaracho Sakyo Kyoto

TEL

81-75-751-3852

Homepage URL


Email

chink@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Philips Respironics

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyoto University, Graduate School of Medicine,Cardiovascular Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT01187823

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

C-447

Org. issuing International ID_2

Ethics Committee of Kyoto University

IND to MHLW



Institutions

Institutions

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 09 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 08 Month 25 Day

Last modified on

2014 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name