UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of ASV treatment for heart failure patients
Title of the study (Brief title)	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
Name of lead principal investigator	Hiroaki Kitaoka, MD
Organization	Kochi Medical School, Kochi University
Division name	Department of Cardiology, Neurology and Aging Science
Address	Kohasu, Nankoku-chi, Kochi-ken, JAPAN
TEL	088-880-2352
Email	kitaokah@kochi-u.ac.jp

Public contact
Name of contact person	Toru Kubo, MD
Organization	Kochi Medical School, Kochi University
Division name	Department of Cardiology, Neurology and Aging Science
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Discontinuance due to understaff
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/icdr_e/ctr_view.cgi?recptno=R000025042