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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028034
Receipt No. R000032098
Scientific Title Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor
Date of disclosure of the study information 2017/07/05
Last modified on 2017/07/01

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Basic information
Public title Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor
Acronym Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor
Scientific Title Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor
Scientific Title:Acronym Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor
Region
Japan

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

Objectives
Narrative objectives1 We evaluate relationship among the nocturnal respiratory stability obtained by contactless sheet sensor system and standard markers of heart failure to confrim the hypothesis that nocturnal respiratory stability is correlated with severity of heart failure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlation among nocturnal respiratory stability and standard markers of heart failure
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 chronic heart failure patients
hospitalized patients
Key exclusion criteria underaged patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Sawa
Organization Osaka University
Division name Department of Cardiovascular Surgery
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka, Japan
TEL 81-6-6879-3154
Email k-domae@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keitaro Domae
Organization Osaka University
Division name Department of Cardiovascular Surgery
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka, Japan
TEL 81-6-6879-3154
Homepage URL http://www2.med.osaka-u.ac.jp/surg1/research/clinical-research/
Email k-domae@surg1.med.osaka-u.ac.jp

Sponsor
Institute Department of Cardiovascular Surgery, Osaka University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 大阪大学付属病院

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 05 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 07 Month 01 Day
Last modified on
2017 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032098

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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