UMIN-CTR Clinical Trial

Basic information
Public title	Impact of Esaxerenone on Left Ventricular Diastolic Function in Heart Failure Patients with Hypertension
Acronym	Impact of Esaxerenone on Left Ventricular Diastolic Function
Scientific Title	Impact of Esaxerenone on Left Ventricular Diastolic Function in Heart Failure Patients with Hypertension
Scientific Title:Acronym	Impact of Esaxerenone on Left Ventricular Diastolic Function
Region	Japan

Condition
Condition	Chronic heart failure patients with hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of esaxerenone on left ventricular diastolic function in chronic heart failure patients with hypertension
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A change in E/e' between baseline and 6 months after the start of administration of esaxerenone.
Key secondary outcomes	A change in brain natriuretic peptide (BNP), left atrial volume index, left venrtricular mass index between baseline and 6 months after the start of administration of esaxerenone.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administration of esaxerenone
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Patients with hypertension (systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than or equal to 90mmHg) (2) Patients with chronic heart failure (NYHA functional classification I-III) (3) NYHA functional classification and receiving cardio-protective drugs such as ACE inhibitors, ARBs, or beta-blockers has been stable for 4 weeks from enrollment
Key exclusion criteria	(1) New onset of acute coronary syndrome, cerebrovascular diseases, myocarditis, constructive pericarditis, severe valvular heart diseases within 3 months. (2) New onset of atrial fibrillation or atrial flutter within 3 months (3) Severe kidney disease (eGFR less than 30 mL/min/1.73 m2 or dialysis patients) (4) Patients with hyperkalemia or serum potassium level>5.0mEq/L at enrollment (5) Patients erceiving potassium-conserving diuretics, mineralocorticoid receptor antagonists, potassium preparations (6) Cancer patients (7) Pregnant women, lactating woman or women who wish to a pregnancy
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hidekazu Middle name Last name Tanaka
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5846
Email	tanakah@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Hidekazu Middle name Last name Tanaka
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5846
Homepage URL
Email	tanakah@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
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	Kobe University Hospital Clinical & Translational Reserch Center
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe
Tel	078-382-6669
Email	cerb@med.kobe-u.ac.jp

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	2019 Year 08 Month 01 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	2019 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 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 07 Month 13 Day
Last modified on	2019 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042581

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.