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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000047636 |
Receipt No. | 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 | 2022/05/01 |
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 |
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Condition | ||
Condition | Heart Failure | |
Classification by specialty |
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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, discontinuance 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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 1000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Toho University Faculty of Medicine |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information | Retrospective observational study |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054320 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |