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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021918
Receipt No. R000025042
Scientific Title Evaluation of ASV treatment for heart failure patients
Date of disclosure of the study information 2016/04/15
Last modified on 2018/05/04

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Basic information
Public title Evaluation of ASV treatment for heart failure patients
Acronym Evaluation of ASV treatment for heart failure patients
Scientific Title Evaluation of ASV treatment for heart failure patients
Scientific Title:Acronym Evaluation of ASV treatment for heart failure patients
Region
Japan

Condition
Condition Heart failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of ASV treatment for heart failure patients
Basic objectives2 Others
Basic objectives -Others Evaluation of ASV treatment for heart failure patients
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of ASV treatment for heart failure patients
Key secondary outcomes None

Base
Study type Others,meta-analysis etc

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 Heart failure patients
Key exclusion criteria Patients with cardiac devices (permanent pacemaker, ICD, CRT and CRT-D)
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kitaoka, MD
Organization Kochi Medical School, Kochi University
Division name Department of Cardiology, Neurology and Aging Science
Zip code
Address Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL 088-880-2352
Email kitaokah@kochi-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toru Kubo, MD
Organization Kochi Medical School, Kochi University
Division name Department of Cardiology, Neurology and Aging Science
Zip code
Address Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL 088-880-2352
Homepage URL http://www.kochi-ms.ac.jp/html/gakubu/fm_gratr.html
Email jm-kubotoru@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School, Kochi University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 高知大学医学部附属病院(Kochi Medical School Hospital)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 15 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
Discontinuance due to understaff
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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2014 Year 03 Month 05 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information Study discontinuance

Management information
Registered date
2016 Year 04 Month 15 Day
Last modified on
2018 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025042

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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