UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure
Acronym	A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure
Scientific Title	A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure
Scientific Title:Acronym	A Prospective Observational Study on the Efficacy of Angiotensin Receptor Neprilysin Inhibitor (ARNI) in Chronic Heart Failure
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to clarify 1) changes in various biomarkers before and after switching from ACE inhibitors or ARBs to ARNI, and 2) the relationship between changes in biomarkers and prognosis, using laboratory data (clinical data, imaging data, blood test results, etc.) from patients with heart failure who had clinical symptoms despite standard treatment according to guidelines and who switched from ACE inhibitors or ARBs to ARNI.
Basic objectives2	Others
Basic objectives -Others	N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in biomarkers before and after the introduction of ARNI
Key secondary outcomes	(1) Relationship between changes in biomarkers and prognosis (2) Comparison of the clinical course of information obtained from medical record data. (3) Correlation with various examinations, symptoms, etc. obtained from the medical record base (4) Examination of factors involved in the effect of treatment obtained from the medical record base

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients who are 18 years of age or older at the time of obtaining consent. (2) Patients who have had inadequate response to standard treatment with ACE inhibitor or ARB according to the guidelines. (3) Patients who have received sufficient explanations and understanding before participating in this study, and who have obtained the free consent of the research subject or his/her guardian.
Key exclusion criteria	(1) Those who are not tolerant of ARNI (2) Those who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Nagai
Organization	Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name	Department of Cardiovascular Medicine
Zip code	060-8638
Address	Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
TEL	011-706-6973
Email	tnagai@huhp.hokudai.ac.jp

Public contact
Name of contact person	1st name Toshiyuki Middle name Last name Nagai
Organization	Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name	Department of Cardiovascular Medicine
Zip code	060-8638
Address	Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
TEL	011-706-6973
Homepage URL
Email	tnagai@huhp.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Non profit foundation
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	Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
Tel	011-706-7636
Email	crjimu@huhp.hokudai.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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 25 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 01 Month 18 Day
Date of IRB	2021 Year 01 Month 18 Day
Anticipated trial start date	2021 Year 01 Month 18 Day
Last follow-up date	2040 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 09 Month 25 Day
Last modified on	2021 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052019