UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single arm prospective observational study for severe heart failure patients repeating hospitalization (multicenter study)
Title of the study (Brief title)	Single arm prospective study for severe HF patients repeating hospitalization
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to analyze the characteristics of the change in vital signs before cardiac failure exacerbation obtained from a noninvasive chest attachment type device and a wireless sensor with communication tools.
Basic objectives2	Others
Basic objectives -Others	Safety,Efficacy
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Re-hospitalization caused by heart failure, all deaths during the study period(0.5 year).
Key secondary outcomes	1) An elevation to more than 1000pg/ml of B-type peptide during the study period. 2) The reason why patients dropped out. 3) An expression of adverse events.

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) Patients who hospitalized caused by severe heart failure within a year. 2) Patients classified NYHA II or III or IV. 3) Patients who agreed to participate in this research by themselves. 4) Patients who were over 20 years old when they agreed to participate in this research.
Key exclusion criteria	1) Patients who wear pace makers, ICD and CRT(D), or are supposed to wear them. 2) Patients who are valued as inappropriate by a doctor to participate in this research.
Target sample size	160

Research contact person
Name of lead principal investigator	Koichiro Kinugawa
Organization	University of Toyama
Division name	Second Department of Internal Medicine
Address	2630 Sugitani, Toyama
TEL	076-434-7297
Email	kinugawa-tky@umin.ac.jp

Public contact
Name of contact person	Shuji Joho
Organization	University of Toyama
Division name	Second Department of Internal Medicine
Address	2630 Sugitani, Toyama
TEL	076-434-7297
Homepage URL
Email	sjoho@med.u-toyama.ac.jp

Sponsor
Institute	1) University of Toyama 2) Tokyo Metropolitan Geriatric Hospital
Institute
Department

Funding Source
Organization	Secom Science and Technology Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo Metropolitan Geriatric Hospital, SECOM Medical System CO.,LTD.
Name of secondary funｄer(s)

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	富山大学附属病院（富山県）、東京大学医学部附属病院（東京都）、東京都健康長寿医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 29 Day
Anticipated trial start date	2015 Year 09 Month 30 Day
Last follow-up date	2018 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Data analysis in progress.

Management information
Registered date	2017 Year 08 Month 24 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032933