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

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 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


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

Value
https://center6.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