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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004099
Receipt No. 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

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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
Institute Kyoto University, Graduate School of Medicine
Institute
Department

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
URL(English) https://upload.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


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