UMIN-CTR Clinical Trial

Basic information
Public title	Cardioprotective effects of angiotensin receptor-neprilysin inhibitors in the real world
Acronym	Cardioprotective effects of angiotensin receptor-neprilysin inhibitors in the real world
Scientific Title	Cardioprotective effects of angiotensin receptor-neprilysin inhibitors
Scientific Title:Acronym	Cardioprotective effects of angiotensin receptor-neprilysin inhibitors
Region	Japan

Condition
Condition	Heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is whether the angiotensin receptor-neprilysin inhibitor(ARNI) administered by daily practice exerts cardioprotective effects.
Basic objectives2	Others
Basic objectives -Others	The purpose is to investigate the mechanisms by which the ARNI exerts its cardioprotective effects.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in NT-proBNP(BNP)(after 6 months or later)
Key secondary outcomes	Changes in troponin I(T), cardiac function(chest X-ray, electrocardiogram and echocardiography), renal function, inflammation, and the presence or absence of major cardiovascular events(MACE)(after 6 months or later)

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	Patients undergoing treatment for heart failure in daily practice who are scheduled to change from angiotensin-converting enzyme inhibitors or angiotensin II receptor blocker to ARNI
Key exclusion criteria	Patients already receiving ARNI Patients who do not change as a result of consideration Patients with severe liver dysfunction (Child-Pugh classification C)
Target sample size	360

Research contact person
Name of lead principal investigator	1st name Shin-ichiro Middle name Last name Miura
Organization	Fukuoka University Hospital
Division name	Department of Cardiology
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka, Japan
TEL	0928011011
Email	miuras@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Yuhei Middle name Miura Last name Shiga
Organization	Fukuoka University Hospital
Division name	Department of Cardiology
Zip code	8140180
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka, Japan
TEL	0928011011
Homepage URL
Email	yuheis@fukuoka-u.ac.jp

Sponsor
Institute	Department of Cardiology, Fukuoka University Hospital
Institute
Department

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

Other related organizations
Co-sponsor	Murakami Karindoh Hospital, Hakujyuji Hospital, Fukuoka University Nishijin Hospital, Izumi General Medical Center, Yakuin Naika Junkanki Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka University Faculty of Medicine
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka, Japan
Tel	0928011011
Email	fumed-ethics@fukuoka-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	2021 Year 02 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	Enrolling by invitation
Date of protocol fixation	2020 Year 12 Month 23 Day
Date of IRB	2021 Year 01 Month 13 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2021 Year 01 Month 31 Day
Last modified on	2021 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049300