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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037113
Receipt No. R000042288
Scientific Title Comparative clinical trial of Eplerenone and Esaxerenone for hypertension with chronic heart failure treating Eplerenone
Date of disclosure of the study information 2019/06/19
Last modified on 2020/09/03

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Basic information
Public title Comparative clinical trial of Eplerenone and Esaxerenone for hypertension with chronic heart failure treating Eplerenone
Acronym Comparative clinical trial of Eplerenone and Esaxerenone for hypertension with chronic heart failure treating Eplerenone
Scientific Title Comparative clinical trial of Eplerenone and Esaxerenone for hypertension with chronic heart failure treating Eplerenone
Scientific Title:Acronym Comparative clinical trial of Eplerenone and Esaxerenone for hypertension with chronic heart failure treating Eplerenone
Region
Japan

Condition
Condition Hypertension with chronic heart failure treating Eplerenone
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reserch the effects of administration of Eplerenone and Esaxerenone for hypertension with chronic heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sCr, eGFR
Key secondary outcomes 1) Blood pressure, heart rate
2) osm, cystitin C, ox-LDL, renin, angiotensin-II, aldosterone, cortisol, Na, K, Cl
3) Urine (albumin, Na, K, Cl, osm, IV-FABP)
4) ANP, BNP
5) UCG (EF,E/e',LVMI), ABI

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switch from Eplerenone 50mg/day to Esaxerenone2.5mg/day
Interventions/Control_2 Switch from Esaxerenone2.5mg/day to Eplerenone 50mg/day
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
90 years-old >
Gender Male and Female
Key inclusion criteria Hypertension with chronic heart failure treating Eplerenone
eGFR>30mL/min/1.73m2
Patients from whom informed consent was obtained
Key exclusion criteria eGFR<29mL/min/1.73m2
Patients from whom informed consent was not obtained
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Sezai
Organization Nihon University school of medicine
Division name Department of Cardiovascular Surgery
Zip code 1738610
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email asezai.med@gmail.com

Public contact
Name of contact person
1st name Mitsue
Middle name
Last name Akiyama
Organization Sekino Laboratory
Division name Department of Research
Zip code 1710014
Address 3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan
TEL 03-3986-5501
Homepage URL
Email skn-np@sekino-hospital.com

Sponsor
Institute Sekino Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sekino Laboratory
Address 3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan
Tel 03-3986-5501
Email skn-np@sekino-hospital.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 関野病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 19 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
2018 Year 12 Month 01 Day
Date of IRB
2019 Year 04 Month 02 Day
Anticipated trial start date
2019 Year 05 Month 15 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 19 Day
Last modified on
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042288

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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