UMIN-CTR Clinical Trial

Basic information
Public title	Reverse remodeling and prognosis of patients with heart failure with reduced ejection fraction treated with angiotensin receptor neprilysin inhibitor using cardiac magnetic resonance imaging
Acronym	ARNI-LGE project
Scientific Title	Reverse remodeling and prognosis of patients with heart failure with reduced ejection fraction treated with angiotensin receptor neprilysin inhibitor using cardiac magnetic resonance imaging
Scientific Title:Acronym	ARNI-LGE project
Region	Japan

Condition
Condition	Heart failure with reduced ejection fraction
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the association between late gadolinium enhancement of CMR and reverse remodeling as well as the prognosis in patients with HFrEF treated with ARNI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Confirmation of predictive value of reverse remodeling and prognosis using late gadolinium enhancement of cardiac MRI
Key secondary outcomes	Exploration of predictive factor for reverse remodeling and prognosis in patients with HFrEF treated with ARNI

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
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Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Heart failure with left ventricular ejection fraction less than 40% Ischemic cardiomyopathy or dilated cardiomyopathy Patient starting ARNI Patient who gave written informed consent
Key exclusion criteria	Severely impaired renal function (eGFR less than 30 mL/min/1.73m2) Etiology other than ischemic cardiomyopathy and dilated cardiomyopathy
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Kenichiro Middle name Last name Suwa
Organization	Hamamatsu University School of Medicine
Division name	Division of Cardiology
Zip code	431-3125
Address	1-20-1 Handayama Higashiku, Hamamatsu
TEL	0534352267
Email	k-suwa@hama-med.ac.jp

Public contact
Name of contact person	1st name Kenichiro Middle name Last name Suwa
Organization	Hamamatsu University School of Medicine
Division name	Division of Cardiology
Zip code	431-3192
Address	1-20-1 Handayama Higashiku, Hamamatsu
TEL	0534352267
Homepage URL	https://www.hama-med.ac.jp/research/21-164.pdf
Email	k-suwa@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology-Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Kondou kinen Medical Foundation

IRB Contact (For public release)
Organization	Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 Handayama Higashiku, Hamamatsu
Tel	053-435-2680
Email	rinri@hama-med.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	浜松医科大学（静岡県） 浜松赤十字病院（静岡県） 磐田市立総合病院（静岡県） 静岡市立静岡病院（静岡県） 聖隷三方原病院（静岡県） 富士宮市立病院（静岡県）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 24 Day

Related information
URL releasing protocol	https://www.hama-med.ac.jp/research/21-164.pdf
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 08 Month 11 Day
Date of IRB	2021 Year 09 Month 13 Day
Anticipated trial start date	2021 Year 09 Month 27 Day
Last follow-up date	2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will evaluate the reverse remodeling of LV using cardiac MRI in patients with HFrEF (ICM or DCM) treated with ARNI. We will also evaluate whether LGE can predict the reverse remodeling of LV.

Management information
Registered date	2021 Year 09 Month 24 Day
Last modified on	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052004