UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046156 |
|---|---|
| Receipt number | R000052689 |
| Scientific Title | Sodium RCT |
| Date of disclosure of the study information | 2021/11/24 |
| Last modified on | 2021/11/24 16:26:47 |
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Basic information
Public title
Sodium RCT
Acronym
Sodium RCT
Scientific Title
Sodium RCT
Scientific Title:Acronym
Sodium RCT
Region
| Japan |
Condition
Condition
Acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of different dietary salt intake on heart failure status and biomarkers in patients admitted to our hospital with acute heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in NT-proBNP from the day of the meal to 1 week later
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
severe low-sodium diet group (salt restriction 3g/day)
Interventions/Control_2
normal low-sodium diet group (6g/day)
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) Age 20 years or older at the time of obtaining consent
2) Patients hospitalized for worsening heart failure with symptoms of heart failure (e.g., respiratory distress at rest or with light exertion) and signs of congestion (e.g., edema, moist chest rales, congestive chest radiographs) (left ventricular ejection fraction is not required)
3) NYHA classification II-IV
4) NT-proBNP becomes more than 1200 pg/mL or BNP becomes more than 300 pg/mL at the time of admission
5) Patients whose condition has been stabilized by initial treatment and are judged to be able to take oral intake
Key exclusion criteria
1) Patient refuses to participate
2) Patients who are judged by their physician to be unable to start a full meal
3) Pregnancy
4) Others who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Matsue |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
Tokyo-to, Bunkyo-ku, Hongo, 3-1-3
TEL
03-3813-3111
taretaishi0731@gmail.com
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | Dotare |
| Last name | Dotare |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
Tokyo-to, Bunkyo-ku, Hongo, 3-1-3
TEL
03-3813-3111
Homepage URL
t-dotare@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
Research Ethics Commiittee, Faculty of Medicine, Juntendo University
Address
Tokyo-to, Bunkyo-ku, Hongo, 3-1-3
Tel
03-3813-3111
t-dotare@juntendo.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 24 | 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
| 2021 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 24 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052689
