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
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
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
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
