UMIN-CTR Clinical Trial

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
Email	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
Email	you617bacchus@gmail.com

Sponsor
Institute	Department of Cardiology, National Hospital Organization Yokohama Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031228