UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028034 |
|---|---|
| Receipt number | 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 | 2020/12/02 13:57:11 |
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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
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/
k-domae@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, Osaka University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032098
