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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034295
Receipt No. R000039099
Scientific Title Prospective cohort Study of Adaptive servo-ventilation therapy on prognosis In repeatedly hospitalized patients with chronic heart failure: Longitudinal observational study of effects on re-admission and mortality
Date of disclosure of the study information 2018/09/29
Last modified on 2020/04/30

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Basic information
Public title Prospective cohort Study of Adaptive servo-ventilation therapy on prognosis In repeatedly hospitalized patients with chronic heart failure: Longitudinal observational study of effects on re-admission and mortality
Acronym SAVIOR-L
Scientific Title Prospective cohort Study of Adaptive servo-ventilation therapy on prognosis In repeatedly hospitalized patients with chronic heart failure: Longitudinal observational study of effects on re-admission and mortality
Scientific Title:Acronym SAVIOR-L
Region
Japan

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

Objectives
Narrative objectives1 To evaluate a variety of clinical questions about ASV therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The length of time between the date of the baseline and the date of death / admission to the hospital from any cause.
Key secondary outcomes The length of time between the date of discharge and the date of cardiac events.
The length of time between the date of discharge and the start date of the first non-drug therapy for cardiac events or exacerbation of heart failure.
Number of hospitalized days for a year from the date of discharge.
Number of hospitalizations for a year from the date of discharge.
The level of improvement of QOL
Clinical composite response
The rate of improvement of natriuretic peptide

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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)Subjects who have been hospitalized at least once due to heart failure within the previous t 1 year from the presentl admission.
(2)Subjects who can regularly visit medical institutions as outpatients after the discharge.
(3)Subjects who can visit the hospital a year after the discharge.
(4)Subjects aged 20 and over at the time of obtaining informed consent.
(5)Subjects who have fully understand the study participation and sign the informed consent form.
Key exclusion criteria (1)Subjects unable to make an independent judgment about participation in the study.
(2)Subjects diagnosed with dementia
(3)Subjects who have been already registered with this study
(4)Subjects currently participating in other clinical trials
(5)Subjects in inappropriate condition for the trial judged by investigators
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name Yasuki
Middle name
Last name Kihara
Organization Kobe City Medical Center General Hospital
Division name Director
Zip code 650-0047
Address 2-1-1 Minatojimaminamimachi,Kobe Chuo-ku,650-0047
TEL 03-5287-2639
Email savior@csp.or.jp

Public contact
Name of contact person
1st name Yuka
Middle name
Last name Nakajima
Organization Public Health Research Foundation (PHRF)
Division name Comprehensive Support Project for Clinical Research of Lifestyle-Related Disease (CSP-LD)
Zip code 169-0051
Address 1-1-7-3F Nishiwaseda,shinjyuku-ku,Tokyo,169-0051
TEL 03-5287-2639
Homepage URL
Email savior@csp.or.jp

Sponsor
Institute Public Health Research Foundation (PHRF)
Comprehensive Support Project for Clinical Research of Lifestyle-Related Disease (CSP-LD)
Institute
Department

Funding Source
Organization TEIJIN PHARMA LIMITED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Public Health Research Foundation (PHRF)
Address 1-1-7-3F Nishiwaseda,shinjyuku-ku,Tokyo,169-0051
Tel 03-5287-2633
Email rinri@phrf.jp

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 広島大学病院(広島県)
自治医科大学附属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)
群馬県立心臓血管センター(群馬県)
富山大学附属病院(富山県)
社会医療法人中央会 尼崎中央病院(兵庫県)
久留米大学病院(福岡県)
東北大学病院(宮城県)
日本医科大学付属病院(東京都)
東京女子医科大学病院(東京都)
北里大学北里研究所病院(東京都)
富山県済生会富山病院(富山県)
兵庫県立尼崎総合医療センター(兵庫県)
兵庫医科大学病院(兵庫県)
徳島大学病院(徳島県)
鳥取大学医学部附属病院(鳥取県)
公益財団法人 大原記念倉敷中央医療機構 倉敷中央病院(岡山県)
愛媛県立中央病院(愛媛県)
公益財団法人 天理よろづ相談所病院(奈良県)
国立研究開発法人 国立循環器病研究センター(大阪府)
公益財団法人田附興風会医学研究所 北野病院(大阪府)
兵庫県立姫路循環器病センター(兵庫県)
独立行政法人国立病院機構 東広島医療センター(広島県)
市立三次中央病院(広島県)
福岡県済生会二日市病院(福岡県)
市立秋田総合病院(秋田県)
長野県厚生農業協同組合連合会 佐久医療センター(長野県)
大垣市民病院(岐阜県)
県立広島病院(広島県)
社会医療法人近森会 近森病院(高知県)
大浜第一病院(沖縄県)
地方独立行政法人 山形県・酒田市病院機構 日本海総合病院(山形県)
獨協医科大学病院(栃木県)
獨協医科大学日光医療センター(栃木県)
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
大阪大学医学部附属病院(大阪府)
埼玉医科大学国際医療センター(埼玉県)
山形大学医学部附属病院(山形県)
北里大学病院(神奈川県)
和歌山県立医科大学附属病院(和歌山県)
神戸大学医学部附属病院(兵庫県)
心臓病センター榊原病院(岡山県)
福岡大学病院(福岡県)
社会医療法人生長会府中病院(大阪府)
昭和大学病院(東京都)
地方独立行政法人 神戸市民病院機構  神戸市立医療センター中央市民病院(兵庫県)
一般財団法人 宮城県成人病予防協会 附属 仙台循環器病センター(宮城県)
日本赤十字社 高松赤十字病院(香川県)
愛知県厚生農業協同組合連合会 豊田厚生病院(愛知県)
医療法人澄心会 岐阜ハートセンター(岐阜県)
地方独立行政法人 東京都健康長寿医療センター(東京都)
日本赤十字社 広島赤十字・原爆記念病院(広島県)
埼玉県立循環器・呼吸器病センター(埼玉県)
地方独立行政法人 大阪府立病院機構 大阪急性期・総合医療センター(大阪府)
日本赤十字社 長野赤十字病院(長野県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 29 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 08 Month 01 Day
Anticipated trial start date
2019 Year 01 Month 18 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2018 Year 09 Month 27 Day
Last modified on
2020 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039099

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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