UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035526 |
|---|---|
| Receipt number | R000040475 |
| Scientific Title | Diuretic Resistance Measured by Sodium Excretion and Urine Output in Acute Heart Failure |
| Date of disclosure of the study information | 2019/01/15 |
| Last modified on | 2022/07/16 14:55:08 |
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Basic information
Public title
Diuretic Resistance Measured by Sodium Excretion and Urine Output in Acute Heart Failure
Acronym
DIURESIS-AHF
Scientific Title
Diuretic Resistance Measured by Sodium Excretion and Urine Output in Acute Heart Failure
Scientific Title:Acronym
DIURESIS-AHF
Region
| Japan |
Condition
Condition
Acute Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate two hypotheses:
- How accurately can urinary sodium excretion achieved within 1 hour after iv furosemide predict urinary sodium excretion achieved within 6 hours?
- Does urinary sodium excretion predict 180-day all cause mortality?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Urinary sodium excretion achieved within 6 hours
2. 180-day all-cause mortality
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
1) Patients diagnosed as acute heart failure fulfilling all the below criteria
- Dyspnea at rest or mild exertion
- Age equal or above 20
- Show at least one sign of congestion inclusion peripheral edema, rale, JVD, congestion shown by chest Xp)
- BNP >=100 pg/mL or NT-proBNP >=300 pg/mL
2) Prescribed at least 10mg oral furosemide at the time of admission
3) Needs treatment with iv furosemide
4) Expected to use urinary catheter at least 6 hours
5) Those who are not obviously inappropriate
Key exclusion criteria
1) eGFR <15 mL/min/1.73m2
2) Cardiogenic shock
3) acute myocarditis, post heart transplantation, needs mechanical circulatory support
4) Already treated with iv furosemide before enrollment
5) Need emergent revascularization with
6) Need treatment with carperitide within 6 hours
7) No consent achieved
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuya Matsue |
Organization
Juntendo University
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
yuya8950@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kitai |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo
TEL
078-302-4321
Homepage URL
t-kitai@kcho.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Funded by the Japanese Circulation Society Clinical Research Grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2019 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040475
| 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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