UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027431 |
|---|---|
| Receipt number | R000031228 |
| Scientific Title | The effect of empagliflozin on diuresis and neurohumoral factors in the patients with decompensated heart failure and diabetes mellitus: pilot study |
| Date of disclosure of the study information | 2017/05/21 |
| Last modified on | 2022/11/24 23:30:05 |
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Basic information
Public title
The effect of empagliflozin on diuresis and neurohumoral factors in the patients with decompensated heart failure and diabetes mellitus: pilot study
Acronym
EmpaHF-P
Scientific Title
The effect of empagliflozin on diuresis and neurohumoral factors in the patients with decompensated heart failure and diabetes mellitus: pilot study
Scientific Title:Acronym
EmpaHF-P
Region
| Japan |
Condition
Condition
decompensated heaat failure
type 2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the diuretic property of the empagliflozin and its effects on the neurohumoral factors in the decompensated heart failure patients with type 2 diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urine output during a day
Key secondary outcomes
amount of furosemide injection intravenously
Holter electrocardiography
Echocardiography
neurohumoral factors
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. The hospitalized decomposed heart failure patients with type 2 diabetes mellitus
2. The type 2 diabetes mellitus patient who is planned empagliflozin administration for poorly controlled hyperglycemia by attending physician
3. Patient who is obtained informed consent
Key exclusion criteria
1. Patient who has contraindication for empagliflozin administration
2. Patient who is in shock at registeration
3. Patient who is undergone or required intra-aortic balloon pumping (IABP), percutaneous cardiopulmonary support (PCPS) and/or dialysis at registration
4. Patient who cannot be obtained informed consent
5. Patient who is judged as unsuitable for this study by attending physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Hasegawa |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Cardiology
Zip code
245-8575
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama-shi, Kanagawa, 245-8575, Japan
TEL
045-851-2621
freelife0608@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Ajiro |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Cardiology
Zip code
245-8575
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama-shi, Kanagawa, 245-8575, Japan
TEL
045-851-2621
Homepage URL
you617bacchus@gmail.com
Sponsor or person
Institute
Department of Cardiology, National Hospital Organization Yokohama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Research, National Hospital Organization Yokohama Medical Center
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
National Hospital Organization Yokohama Medical Center
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama-shi, Kanagawa, 245-8575, Japan
Tel
045-851-2621
you617bacchus@gmail.com
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
国立病院機構横浜医療センター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
urinary output for a day and neurohumoral factors before and after empaglifrozine administration will be compared by means of paired t test
Management information
Registered date
| 2017 | Year | 05 | Month | 21 | Day |
Last modified on
| 2022 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031228
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
