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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029129
Receipt No. R000031421
Scientific Title Evaluation of neurohumoral factors and water clearance for treating acute decompensated heart failure with salt
Date of disclosure of the study information 2017/09/13
Last modified on 2017/09/13

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Basic information
Public title Evaluation of neurohumoral factors and water clearance for treating acute decompensated heart failure with salt
Acronym Enter-salt
Scientific Title Evaluation of neurohumoral factors and water clearance for treating acute decompensated heart failure with salt
Scientific Title:Acronym Enter-salt
Region
Japan

Condition
Condition Acute decompensated heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate how hypertonic saline plus low-dose furosemide affects neurohumoral factors and water clearance in the treatment of acute decompensated heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes 1. Change in serum anti-diuretic hormone during 24 hours
2. Change in urine clearance during 24 hours
Key secondary outcomes 1. Change in serum osmolality during 24 hours
2. Change in urinary osmolality during 24 hours
3. Change in urinary volume during 24 hours
4. Change in systolic blood pressure during 24 hours
5. Change in diastolic blood pressure during 24 hours
6. Change in heart rate during 24 hours
7. Change in serum sodium level during 24 hours
8. Change in serum potassium during 24 hours
9. Change in serum chloride during 24 hours
10. Change in urinary sodium level during 24 hours
11. Change in urinary potassium during 24 hours
12. Change in urinary chloride during 24 hours
13. Change in plasma aldosterone concentration during 24 hours
14. Change in plasma renin activity during 24 hours
15. Change in plasma catecholamine during 24 hours
16. Change in blood urea nitrogen during 24 hours
17. Change in urinary urea nitrogen during 24 hours
18. Change in serum creatinine during 24 hours

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Hypertonic saline group: continuous intravenous infusion of 120mL 2.4% hypertonin saline for 1 hour after bolus injection of 40mg furosemide.
Interventions/Control_2 Glucose group: continuous intravenous infusion of 120mL 5 % glucose solution for 1 hour after bolus infusion of 40mg furosemide.
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 with age 20 and over.
2. Patients who are hospitalized due to acute decompensated heart failure
3. Patients who gave written informed consent
Key exclusion criteria 1. Patients with less than 90mmHg of systolic blood pressure
2. Patients with acute coronary sydrome
3. Patients requiring intra-aortic balloon pump therapy and extracorporeal circulation system
4. Patients with severe kidney disease(less than 15ml/min/1.73m2 of eGFR)
5. Patients with regular hemodialysis
6. Patients with more than 148mEq/L of serum sodium level
7. Patients with endocrine disease (eg: SIADH and aldosteronism)
8. Patients who already participate in other clinical trials or plan to participate during this study
9. For other reasons, patients whom the investigators deem inappropriate to participate in this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Masuyama
Organization Hyogo College of Medicine
Division name Department of Internal Medicine, Cardiovascular Division/Division of Coronary Heart Disease, Hyogo College of Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 663-8501, Japan
TEL 0798-45-6553
Email masuyama@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Okuhara
Organization Hyogo College of Medicine
Division name Department of Internal Medicine, Cardiovascular Division, Hyogo College of Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 663-8501, Japan
TEL 0798-45-6553
Homepage URL
Email okuhara@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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
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
2017 Year 09 Month 13 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 06 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 13 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 09 Month 13 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031421

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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