UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030266 |
|---|---|
| Receipt number | R000034566 |
| Scientific Title | Impact of extracellular water-to-total body water ratio using bioelectrical impedance analysis in patients with heart failure |
| Date of disclosure of the study information | 2017/12/05 |
| Last modified on | 2017/12/05 12:58:54 |
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Basic information
Public title
Impact of extracellular water-to-total body water ratio using bioelectrical impedance analysis in patients with heart failure
Acronym
Extracellular water-to-total body water ratio in patients with heart failure
Scientific Title
Impact of extracellular water-to-total body water ratio using bioelectrical impedance analysis in patients with heart failure
Scientific Title:Acronym
Extracellular water-to-total body water ratio in patients with heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of the measurement of body composition and edema status based on extracellular water (ECW)-to-total body water (TBW) ratio using bioelectrical impedance analysis (BIA) for estimating heart failure status, efficacy of treatment and predicting outcome in patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between rate of change in ECW/TBW ratio and conventional parameters (body weight, echographic parameters and BNP or NT-proBNP values) at acute and chronic phase
Key secondary outcomes
Relationship of stable-phase ECW/TBW ratio or rate of change in ECW/TBW ratio and all cause death and major adverse outcomes (cardiovascular death and heart failure-related re-admission)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of extracellular water (ECW)-to-total body water (TBW) ratio using bioelectrical impedance analysis (BIA) and conventional parameters (body weight, echographic parameters and BNP or NT-proBNP values) at acute and chronic phase in hospitalized patients with heart failure
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
Patients required hospitalization due to heart failure
Key exclusion criteria
1. Patients with pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devise
2. Inadequate patients by physician's discresion
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yunoki |
Organization
Tsuyama Chuo Hospital
Division name
Department of Cardiology
Zip code
Address
1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL
0868-21-8111
kei.yunoki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Nanba |
Organization
Tsuyama Chuo Hospital
Division name
Department of Cardiology
Zip code
Address
1756, Kawasaki, Tsuyama-City, Okayama, Japan
TEL
0868-21-8111
Homepage URL
http://www.tch.or.jp/clinical_research.html
d5w8y.nmb@gmail.com
Sponsor or person
Institute
Department of Cardiology, Tsuyama Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsuyama Chuo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
津山中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 05 | Day |
Last modified on
| 2017 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034566
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
