UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034295 |
|---|---|
| Receipt number | 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 | 2024/05/08 17:07:52 |
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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
078-302-4321
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
savior@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation (PHRF)
Comprehensive Support Project for Clinical Research of Lifestyle-Related Disease (CSP-LD)
Institute
Department
Personal name
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
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)
独立行政法人国立病院機構 大阪医療センター(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)
国立研究開発法人国立国際医療研究センター病院（東京都）
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38569914/
Number of participants that the trial has enrolled
845
Results
Of 845 patients, 110 (13%) received chronic ASV at hospital discharge. The primary outcome was a composite of all-cause death and urgent rehospitalization for HF, and was observed in 272 patients over a one year follow-up. Following 1:3 sequential propensity score matching, 384 patients were included in the subsequent analysis. The median time to the primary outcome was significantly shorter in the ASV than in non-ASV group (19.7 vs. 34.4 weeks; P=0.013).
Results date posted
| 2024 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 04 | Month | 02 | Day |
Baseline Characteristics
There were 110 patients (83 men, 27 women) in the ASV group and 735 (457 men, 278 women) in the non-ASV group. The ASV group primarily included patients with more severe HF, as evidenced by a higher prevalence of NYHA Class III or IV and more patients with an LVEF <40%, lower mean SBP, higher mean pulse rate, more previous hospitalizations, elevated mean NT-proBNP concentration, lower mean eGFR, and increased use of tolvaptan in comparison with the non-ASV group. Furthermore, the age profile was younger and there were more men in the ASV than non-ASV group. In terms of previous use of ASV and continuous positive airway pressure, 50.9% and 7.3% of patients in the ASV group had a history of these therapies, respectively, compared with 1.2% and 5.9% in the non-ASV group.
Participant flow
In total, 864 patients were enrolled. After 19 exclusions, the final study cohort comprised 845 patients.
There were 110 patients in the ASV group and 735 in the non-ASV group.
Adverse events
Not collected
Outcome measures
The primary outcome was a composite of all-cause death and urgent rehospitalization for HF, and was observed in 272 patients over a 1-year follow-up. Following 1:3 sequential propensity score matching, 384 patients were included in the subsequent analysis. The median time to the primary outcome was significantly shorter in the ASV than in non-ASV group (19.7 vs. 34.4 weeks; P=0.013). In contrast, there was no significant difference in the all-cause mortality event-free rate between the 2 groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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 | 12 | 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
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039099
