UMIN-CTR Clinical Trial

Basic information
Public title	Real-World Evidence of Angiotensin Receptor-Neprilysin Inhibitor in Patients with Heart Failure (REVIEW-HF)
Acronym	REVIEW-HF
Scientific Title	Real-World Evidence of Angiotensin Receptor-Neprilysin Inhibitor in Patients with Heart Failure (REVIEW-HF)
Scientific Title:Acronym	REVIEW-HF
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of angiotensin receptor-neprilysin inhibitor (ARNI) in patients with heart failure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse events (symptomatic/asymptomatic hypotension, hyperkalemia, angioedema, discontinuance of ARNI)
Key secondary outcomes

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 with the initiation of treatment with ARNI from June 29, 2020 to August 31, 2021.
Key exclusion criteria	1. Under 20 years old. 2. Refusal to participate. 3. The cases considered inappropriate.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Matsumoto
Organization	Toho University Faculty of Medicine
Division name	Department of Cardiology
Zip code	143-8541
Address	6-11-1 Omorinishi, Otaku, Tokyo, Japan
TEL	+81337624151
Email	shingomatsumoto0606@gmail.com

Public contact
Name of contact person	1st name Shingo Middle name Last name Matsumoto
Organization	Toho University Faculty of Medicine
Division name	Department of Cardiology
Zip code	143-8541
Address	6-11-1 Omorinishi, Otaku, Tokyo, Japan
TEL	+81337624151
Homepage URL
Email	shingomatsumoto0606@gmail.com

Sponsor
Institute	Toho University Faculty of Medicine
Institute
Department

Funding Source
Organization	Toho University Faculty of Medicine
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	Toho University Faculty of Medicine
Address	6-11-1 Omorinishi, Otaku, Tokyo, Japan
Tel	+81337624151
Email	omori.rinri@ext.toho-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	兵庫県立淡路医療センター、岩手医科大学、順天堂大学医学部附属順天堂医院、聖マリアンナ医科大学、北里大学、国立循環器病センター、奈良県立医科大学、手稲渓仁会病院、久留米大学病院、聖隷浜松病院、弘前大学医学部附属病院、東海大学付属病院、三井記念病院、大阪医科薬科大学病院、大阪急性期・総合医療センター、東邦大学医療センター大橋病院、日本医科大学付属病院、日本大学医学部附属板橋病院

Other administrative information
Date of disclosure of the study information	2022 Year 05 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	Open public recruiting
Date of protocol fixation	2021 Year 12 Month 01 Day
Date of IRB	2022 Year 01 Month 25 Day
Anticipated trial start date	2022 Year 01 Month 25 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observational study

Management information
Registered date	2022 Year 05 Month 01 Day
Last modified on	2022 Year 05 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054320

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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