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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006549
Receipt No. R000007761
Scientific Title Randomized controlled Study of Adaptive-servo Ventilator in patients with congestive heart failure: Confirmatory trial of efficacy on cardiac function
Date of disclosure of the study information 2011/10/17
Last modified on 2015/10/09

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Basic information
Public title Randomized controlled Study of Adaptive-servo Ventilator in patients
with congestive heart failure: Confirmatory trial of efficacy on cardiac function
Acronym SAVIOR-C
Scientific Title Randomized controlled Study of Adaptive-servo Ventilator in patients
with congestive heart failure: Confirmatory trial of efficacy on cardiac function
Scientific Title:Acronym SAVIOR-C
Region
Japan

Condition
Condition congestive heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aime of this clinical trial is to confirm Adaptive-Servo Ventilator would be effective on cardiac function in patients with congestive heart failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Left Ventricular Ejection Fraction(LVEF)
Key secondary outcomes Events,BNP,Clinical composite responce

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 adaptive-servo ventilator
Interventions/Control_2 control
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)The patients with conjestive heart failure under the conventional therapies
(2)The outpatients could be well addapted Adaptive-Servo Ventilator
(3)NYHA score>=2 in Run-in period
(4)LVEF<40% in Run-in period
Key exclusion criteria (1)The patients that Adaptive-Servo Ventilator would not be effective
(2)The patients should be avoided to apply Adaptive-Servo Ventilator
(3)Dementia or suspected
(4)difficult to get Informed-Concent
(5)under other clinical researches or trials
(6)Investigator could judge to be exclusive

Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichi Momoura
Organization Saitama medical center, Jichi Medical University
Division name First department of integrated medicine
Zip code
Address 1-847 Amanuma-cho, Omiyaku-ku, Saitama, Saitama 330-8503 Japan
TEL 048-647-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Tanaka
Organization Public Health Reseach Foundation
Division name CSP-LD Secretariat
Zip code
Address 1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo
TEL 03-5287-2633
Homepage URL
Email tanaka@crsu.org

Sponsor
Institute Saitama medical center, Jichi Medical University
Institute
Department

Funding Source
Organization Public Health Reseach Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 自治医科大学さいたま医療センター(埼玉県)
日本医科大学千葉北総病院(千葉県)
広島大学病院(広島県)
群馬県立心臓血管センター(群馬県)
国立病院機構大阪医療センター(大阪府)
国立循環器病センター(大阪府)
北海道大学病院(北海道)
東北大学病院(宮城県)
榊原記念病院(東京都)
富山大学附属病院(富山県)
射水市民病院(富山県)
名古屋大学医学部附属病院(愛知県)
三重大学医学部附属病院(三重県)
兵庫医科大学病院(兵庫県)
徳島大学病院(徳島県)
福岡県済生会二日市病院(福岡県)
九州大学大学院(福岡県)
熊本大学医学部附属病院(熊本県)
日本医科大学付属病院(東京都)
慶応義塾大学病院(東京都)
防衛医科大学校病院(埼玉県)
安城更生病院(愛知県)
名古屋医療センター(愛知県)
名古屋掖済会病院(愛知県)
東住吉森本病院(大阪府)
関西ろうさい病院(兵庫県)
姫路循環器病センター(兵庫県)
東広島医療センター(広島県)
三次中央病院(広島県)
産業医科大学病院(福岡県)
琉球大学医学部附属病院(沖縄県)
小倉記念病院(福岡県)
松山赤十字病院(愛媛県)
愛媛県立中央病院(愛媛県)
長野中央病院(長野県)
北野病院(大阪府)
埼玉医科大学国際医療センター(埼玉県)
天理よろづ相談所病院(奈良県)
大阪赤十字病院(大阪府)
順天堂大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 17 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4331142/
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/79/5/79_CJ-15-0221/_pdf
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
2011 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2013 Year 11 Month 30 Day
Date of closure to data entry
2014 Year 05 Month 31 Day
Date trial data considered complete
2014 Year 09 Month 30 Day
Date analysis concluded
2014 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 16 Day
Last modified on
2015 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007761

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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