UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062561 |
|---|---|
| Receipt number | R000068279 |
| Scientific Title | The Expanding Landscape of Transthyretin Amyloid Cardiomyopathy and the Question of Circulating Transthyretin Concentration |
| Date of disclosure of the study information | 2026/08/12 |
| Last modified on | 2026/08/12 14:48:19 |
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Basic information
Public title
Validation of Transthyretin Concentration in the Treatment of Transthyretin Amyloidosis
Acronym
Validation of Transthyretin Concentration
Scientific Title
The Expanding Landscape of Transthyretin Amyloid Cardiomyopathy and
the Question of Circulating Transthyretin Concentration
Scientific Title:Acronym
The Question of Circulating Transthyretin Concentration
Region
| Japan |
Condition
Condition
Wild type transthyretin amyloidosis
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Wild-type transthyretin amyloidosis (ATTRwt amyloidosis), caused by the age-related destabilization of the transthyretin (TTR) tetramer, has has garnered significant attention in aging societies. The advent of disease-modifying therapies for ATTR amyloidosis, such as TTR stabilizers, offers effective treatment but has simultaneously sparked debate regarding the appropriate TTR concentration to target during therapy. This study focused on the underlying clinical factors contributing to the increase in TTR concentration after the initiation of tafamidis treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of background factors contributing to increase transthyretin concentration before and one year after tafamidis initiation.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Retrospective study involving all patients with ATTRwt amyloidosis who initiated oral tafamidis treatment at Shinshu University Hospital between September 2019 and September 2025.Patients were retrospectively enrolled if they had documented serum TTR concentration measurements both before (baseline) and 1 year after the initiation of tafamidis.
Key exclusion criteria
Exclusion criteria included the absence of both pre- and 1-year post-treatment serum TTR measurements and cases lost to follow-up.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Yoshie |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, 390-8621, Japan
TEL
0263-37-3486
kojiyoshie@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Yoshie |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, 390-8621, Japan
TEL
0263-37-3486
Homepage URL
https://shinshu-junkanki.jp
kojiyoshie@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Koji Yoshie
Funding Source
Organization
None
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
Research ethics committee of the faculty of medicine, Shinshu University
Address
3-1-1 Asahi, Matsumoto, 390-8621, Japan
Tel
0263-37-2711
kojiyoshie@shinshu-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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 12 | 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
62
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
| 2025 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068279
