UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of neurohumoral factors and water clearance for treating acute decompensated heart failure with salt
Title of the study (Brief title)	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	Tohru Masuyama
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine, Cardiovascular Division/Division of Coronary Heart Disease, Hyogo College of Medicine
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	Yoshitaka Okuhara
Organization	Hyogo College of Medicine
Division name	Department of Internal Medicine, Cardiovascular Division, Hyogo College of Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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