UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046146 |
|---|---|
| Receipt number | 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 | 2023/05/26 14:54:09 |
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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
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
kgnb_27_hot@yahoo.co.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1007
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
No longer recruiting
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
| 2023 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052578
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
