UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045562
Receipt number R000052004
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
Date of disclosure of the study information 2021/09/24
Last modified on 2022/04/05 17:26:52

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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


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

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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052004


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name