UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047161 |
|---|---|
| Receipt number | R000053797 |
| Scientific Title | Efficacy of urine sodium content measurement at 1 h after intravenous furosemide administration in patients with acute decompensated heart failure |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2026/02/16 12:07:30 |
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Basic information
Public title
Efficacy of urine sodium content measurement at 1 h after intravenous furosemide administration in patients with acute decompensated heart failure
Acronym
Efficacy of urine sodium content measurement at 1 h after intravenous furosemide administration
Scientific Title
Efficacy of urine sodium content measurement at 1 h after intravenous furosemide administration in patients with acute decompensated heart failure
Scientific Title:Acronym
Efficacy of urine sodium content measurement at 1 h after intravenous furosemide administration
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate clinical efficacy of urine sodium content measurement after initial intravenous furosemide administration on congestion relief and prognosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of congestion score
Key secondary outcomes
All-cause mortality (1-year)
Rehospitalization due to heart failure (during 1-year)
Change in body weight during initial hospitalization
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
1. Patients required intravenous furosemide administration due to symptoms or signs due to fluid retention
2. Patients required hospital admission
Key exclusion criteria
1. Patients underwent hemodialysis or anuria
2. Patients who are considered not suitable for inclusion of this study
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Mitsutoshi |
| Middle name | |
| Last name | Oguri |
Organization
Kasugai Municipal Hospital
Division name
Department of Cardiology
Zip code
4868510
Address
1-1-1 Takaki-cho, Kasugai city, Aichi
TEL
0568-57-0057
oguricap0909@gmail.com
Public contact
Name of contact person
| 1st name | Mitsutoshi |
| Middle name | |
| Last name | Oguri |
Organization
Kasugai Municipal Hospital
Division name
Department of Cardiology
Zip code
4868510
Address
1-1-1 Takaki-cho, Kasugai city, Aichi
TEL
0568-57-0057
Homepage URL
oguricap0909@gmail.com
Sponsor or person
Institute
Department of Cardiology, Kasugai Municipal Hospital
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
Kasugai Municipal Hospital
Address
1-1-1 Takaki-cho, Kasugai city, Aichi
Tel
0568-57-0057
byouin@hospital.kasugai.aichi.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
| 2022 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
450
Results
The median improvement in CSI in the UNa <70 mEq/L group was significantly smaller than that in the UNa >70 mEq/L group. Multivariable logistic regression analysis demonstrated that the serum sodium and C-reactive protein levels and preadmission beta-blocker use were significantly associated with a UNa of <70 mEq/L. An analysis stratified by the median value (20%) of CSI improvement demonstrated that patients with a <20% improvement in CSI had higher rates of UNa <70 mEq/L.
Results date posted
| 2026 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Radiographic signs of congestion were compared between patients with a UNa of <70 mEq/L (n = 42) and patients with a UNa of >=70 mEq/L (n = 408) using the congestion score index (CSI) measured on days 1 and 3.
Participant flow
A total of 450 patients diagnosed with acute decompensated HF who required intravenous furosemide were enrolled. Diuretic therapy was guided by an algorithm based on the UNa measured 1 h after intravenous furosemide administration.
Adverse events
N/A
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Urine sodium content measurement is scheduled 1 h after intravenous furosemide administration. In patients with urine sodium content > 50-70 mEq/L at 2 h (satisfactory furosemide response), similar furosemide dose i.v. every 12 h. In patients with urine sodium content < 50-70 mEq/L at 2 h (insufficient furosemide response), furosemide i.v. dose can be doubled or other diuretics acting at different sites may be considered. This diuretics treatment flow is adopted by the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Urine sodium content is just a guide for initial treatment with diuretics. Patients should be treated with changes in symptoms, respiratory condition, and urine dose.
Management information
Registered date
| 2022 | Year | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053797
