UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004335 |
|---|---|
| Receipt number | R000005193 |
| Scientific Title | Retrospective cohort study on effects of adaptive-servo ventilator in patients with congestive heart failure : Real World Observation Study |
| Date of disclosure of the study information | 2010/10/08 |
| Last modified on | 2015/10/09 15:47:29 |
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Basic information
Public title
Retrospective cohort study on effects of adaptive-servo ventilator in patients with congestive heart failure : Real World Observation Study
Acronym
Retrospective cohort study on effects of ASV in patients with congestive heart failure(SAVIOR-R)
Scientific Title
Retrospective cohort study on effects of adaptive-servo ventilator in patients with congestive heart failure : Real World Observation Study
Scientific Title:Acronym
Retrospective cohort study on effects of ASV in patients with congestive heart failure(SAVIOR-R)
Region
| Japan |
Condition
Condition
Congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To discover particulars of the ASV applied patients with congestive heart failure, survey changes in outcomes before and after ASV application.
Basic objectives2
Others
Basic objectives -Others
Age, gender, height, onset of heart failure, basal heart diseases,
complications, medical history,
ASV application data, frequency of hospitalization, vital sign, symptom of heart failure, physical findings, biomedical test, plasma level of BNP, echocardiography,
Chest-Xray, clinical impression,
Holter monitoring, polysomnography
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
frequency of hospitalization, vital sign, symptom of heart failure, physical findings, biomedical test, plasma level of BNP, echocardiography,
Chest-Xray,
Holter monitoring, polysomnography
Key secondary outcomes
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
Patient with congestive heart failure
firstly applied with ASV in 2009,at the age was over 20 years.
Key exclusion criteria
Patient that investigator judge to be exclusive
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Momomura |
Organization
Saitama medical center,Jichi medical University
Division name
First department of integrated medicine
Zip code
Address
1-847 Amanuma, Omiya-ku, Saitama, Saitama 330-8503 Japan
TEL
048-647-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Tanaka |
Organization
Public Health Research Foundation
Division name
CSP-LD Secretariat
Zip code
Address
1-1-7 Nishiwaseda,Shinjuku-ku,Tokyo
TEL
03-5287-2633
Homepage URL
tanaka@crsu.org
Sponsor or person
Institute
Saitama medical center,Jichi medical University
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Public Health Research Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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)
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)
慶応義塾大学病院(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)
広島大学病院(広島県)
徳島大学病院(徳島県)
福岡県済生会二日市病院(福岡県)
熊本大学医学部附属病院(熊本県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25103691
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 | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Age, gender, height, onset of heart failure, basal heart diseases,
complications, medical history,
ASV application data, frequency of hospitalization, vital sign, symptom of heart failure, physical findings, biomedical test, plasma level of BNP, echocardiography,
Chest-Xray, clinical impression,
Holter monitoring, polysomnography
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2015 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005193
| 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 |
