UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047636 |
|---|---|
| Receipt number | R000054320 |
| Scientific Title | Real-World Evidence of Angiotensin Receptor-Neprilysin Inhibitor in Patients with Heart Failure (REVIEW-HF) |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2024/05/01 20:13:18 |
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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, discontinuation 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
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
shingomatsumoto0606@gmail.com
Sponsor or person
Institute
Toho University Faculty of Medicine
Institute
Department
Personal name
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
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
Completed
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 | 02 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 01 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2022 | Year | 05 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054320
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