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
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
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
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 | |
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| Registered date | File name |
