UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029129 |
|---|---|
| Receipt number | 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 15:10:28 |
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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
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
okuhara@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031421
