UMIN-CTR Clinical Trial

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
Email

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
Email	tanaka@crsu.org

Sponsor
Institute	Saitama medical center,Jichi medical University
Institute
Department

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
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) 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
URL(English)	https://upload.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
Registered date	File name

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