UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026665 |
|---|---|
| Receipt number | R000028890 |
| Scientific Title | Effectiveness of Sodium Restriction in Japanese patients with Chronic Heart Failure |
| Date of disclosure of the study information | 2017/03/23 |
| Last modified on | 2017/03/29 04:32:31 |
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Basic information
Public title
Effectiveness of Sodium Restriction in Japanese patients with Chronic Heart Failure
Acronym
Effectiveness of Sodium Restriction in Japanese patients with Chronic Heart Failure
Scientific Title
Effectiveness of Sodium Restriction in Japanese patients with Chronic Heart Failure
Scientific Title:Acronym
Effectiveness of Sodium Restriction in Japanese patients with Chronic Heart Failure
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ESR-HF study is designed to investigate the effect of sodium restriction for Japanese patients with chronic heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
clinical stability(clinical congestion score: CCS) at 7-day assessment is the primary end point.
Key secondary outcomes
BNP, NT-proBNP, ANP, body weight, use of diuretics, sodium, Inbody, CTR, QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The control group followed a diet with normal sodium restriction(maximum dietary intake, 6g/d), carried out until day8.
Interventions/Control_2
The study intervention consisted of strict sodium restriction(maximum dietary intake, 3g/d), carried out until hospital day 8.
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 who meet all of the following criteria are included in this study.
1.Patients who are admitted to Tokyo women's medical university cardiology department.
2.Patients who are at age of 20 at the time of consenting.
3.The heart failure is diagnosed according to Framingham criteria.
4.Patients with heart failure classified as AHA stage C to D.
5.Patients who are capable of giving their consent in a written form.
Key exclusion criteria
1.Patients are admitted as Acute heart failure, Acute on chronic heart failure,and who need using mechanical support or infusion of a diuretic.
2.Acute coronary syndrome require emergent revascularization.
3.Patients who are pathologically difficult to ingest.
4.Patients with dialysis therapy.
5.Patients with Na levels =< 130 mEq/L
6.Patients with Hb levels =< 10.0mg/dl
7.Patients with malignancy(except those who are completely cured)
8.Patients with infection treatment.
9.Patients with other conditions that the attending physician think inappropriate to participate in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Hagiwara |
Organization
Tokyo Women's medical University
Division name
cardiology
Zip code
Address
Kawadacho 8-1,Shinjuku-ku,Tokyo
TEL
03-3353-8111
makiko01035@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimura Makiko |
Organization
Tokyo Womens Medical University
Division name
Cardiology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
makiko01035@hotmail.co.jp
Sponsor or person
Institute
Tokyo Women's Medical University, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Womens Medical University
Organization
Division
Category of Funding Organization
Other
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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 | 03 | Month | 23 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028890
| Research Plan | |
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| Registered date | File name |
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