UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058120 |
|---|---|
| Receipt number | R000066429 |
| Scientific Title | Establishment of a New Classification of Calcific Aortic Stenosis: Multicenter Aortic Stenosis Research Observational Network |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/06/08 14:00:56 |
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Basic information
Public title
Establishment of a New Classification of Calcific Aortic Stenosis: Multicenter Aortic Stenosis Research Observational Network
Acronym
MARON study
Scientific Title
Establishment of a New Classification of Calcific Aortic Stenosis: Multicenter Aortic Stenosis Research Observational Network
Scientific Title:Acronym
MARON study
Region
| Japan |
Condition
Condition
Aortic Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is considerable individual variability in the progression of aortic valve stenosis (AS), with a subset of patients experiencing rapid progression.This study aims to establish a more individualized classification of calcific AS.
Basic objectives2
Others
Basic objectives -Others
as above
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in AV peak velocity at 12 months
Key secondary outcomes
Changes in echocardiographic parameters at 6 and 12 months
Change in aortic valve calcification score/calcification density at 12 months
TAVR/SAVR
Incidence of heart failure, cardiovascular death, and all-cause mortality
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
| 60 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
From April 2016 to March 2025, echocardiographic follow-up will be performed for patients with moderate or severe AS, with at least 6 months between the dates of the echocardiographic follow-up.
Calcified tricuspid aortic valve stenosis
Key exclusion criteria
Bicuspid valve AS Congenital AS
After AVR/TAVR
dialysis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Toda |
Organization
Okayama University Hospital
Division name
Department of Cardiovascular medicine
Zip code
7008558
Address
2-5-1 Shikata-cho, Kitaku, Okayama
TEL
0862357351
hiromail1979@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Toda |
Organization
Okayama University Hospital
Division name
Department of Cardiovascular medicine
Zip code
7008558
Address
2-5-1 Shikata-cho, Kitaku, Okayama
TEL
0862357351
Homepage URL
hiromail1979@s.okayama-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular medicine, Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
Okayama University Graduate School of Medicine Ethics Committee
Address
2-5-1 Shikata-cho, Kitaku, Okayama
Tel
0862356938
mae6605@adm.okayama-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Okayama University Hospital,
Tsuyama Chuo Hospital,
Fukuyama Cardiovascular Hospital
Kagawa Prefectural Central Hospital,
Takamatsu Red Cross Hospital
Management information
Registered date
| 2025 | Year | 06 | Month | 08 | Day |
Last modified on
| 2025 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066429
