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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035526
Receipt No. 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 2019/01/12

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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
Email 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
Email t-kitai@kcho.jp

Sponsor
Institute Department of Cardiovascular Medicine, Juntendo University
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 15 Day
Last follow-up date
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
2019 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040475

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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