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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046146
Receipt No. R000052578
Scientific Title REal-world obserVational study for invEstigAting the prevaLence and therapeutic options for Atrial Functional Mitral Regurgitation
Date of disclosure of the study information 2021/11/30
Last modified on 2021/12/01

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Basic information
Public title REal-world obserVational study for invEstigAting the prevaLence and therapeutic options
for Atrial Functional Mitral Regurgitation
Acronym REVEAL-AFMR
Scientific Title REal-world obserVational study for invEstigAting the prevaLence and therapeutic options
for Atrial Functional Mitral Regurgitation
Scientific Title:Acronym REVEAL-AFMR
Region
Japan

Condition
Condition Atrial functional mitral regurgitation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the incidence, treatment option, and its efficacy of atrial functional mitral regurgitation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Combined endpoint of heart failure hospitalization and all-cause death
Key secondary outcomes Cardiovascular death, non-cardiac death, stroke, major adverse cardiac events, sudden cardiac death, heart failure hospitalization, change in echocardiographic and clinical parameters

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 1-Age 20 years or older at the time of enrollment
2-Preserved left ventricular function (left ventricular ejection fraction of 50% or more)
3-Left atrial enlargement (left atrial volume index of 38 mL/m2 or more for men and 41 mL/m2 or more for women. However, if the left atrial volume index is not shown, left atrial diameter of 40mm or more for men and 37mm or more for women)
4-Moderate or severe mitral regurgitation
Key exclusion criteria 1.Patients with organic changes in mitral valve leaflets, i.e. rheumatic changes, prolapse, chordae rupture, infective endocarditis, radiation changes, severe calcification, congenital morphological abnormalities, etc.
2.MR due to mitral valve systolic anterior motion3.Patients with congenital heart disease except for those with a patent foramen ovale
4.Patients with mechanical circulatory assist device
5.Patients with history of mitral valve surgery or heart transplantation
6.Patients with acute heart failure
7.Others who are judged to be inappropriate as research subjects by the principal investigator
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Kagiyama
Organization Juntendo University
Division name Department of Cardiovascular Biology and Medicine
Zip code 113-8431
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kgnb_27_hot@yahoo.co.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Kagiyama
Organization Juntendo University
Division name Department of Cardiovascular Biology and Medicine
Zip code 113-8431
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email kgnb_27_hot@yahoo.co.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee Faculty of Medicine, Juntendo University
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel 03-3813-3111
Email hongo-rinri@juntendo.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 順天堂大学医学部附属順天堂医院(東京都)
群馬大学医学部附属病院(群馬県)
筑波大学附属病院(茨木県)
国立循環器病研究センター(大阪府)
東海大学医学部付属病院(神奈川県)
聖マリアンナ医科大学病院(神奈川県)
神戸市立医療センター中央市民病院(兵庫県)
徳島大学病院(徳島県)
東京ベイ・浦安市川医療センター(千葉県)
弘前大学医学部附属病院(青森県)
虎の門病院(東京都)
藤田医科大学病院(愛知県)
神戸大学医学部附属病院(兵庫県)
榊原記念病院(東京都)
東北大学病院(宮城県)
札幌医科大学附属病院(北海道)
昭和大学病院(東京都)
手稲渓仁会病院(北海道)
帝京大学医学部附属病院(東京都)
島根大学医学部附属病院(島根県)
岡山大学病院(岡山県)
大阪市立総合医療センター(大阪府)
大阪大学医学部附属病院(大阪府)
千葉大学医学部附属病院(千葉県)
北野病院(大阪府)
星ヶ丘医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 30 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 Preinitiation
Date of protocol fixation
2021 Year 09 Month 15 Day
Date of IRB
2021 Year 10 Month 15 Day
Anticipated trial start date
2022 Year 01 Month 01 Day
Last follow-up date
2023 Year 01 Month 01 Day
Date of closure to data entry
2023 Year 01 Month 01 Day
Date trial data considered complete
2023 Year 06 Month 01 Day
Date analysis concluded

Other
Other related information Retrospective data collection

Management information
Registered date
2021 Year 11 Month 23 Day
Last modified on
2021 Year 12 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052578

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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