UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061396 |
|---|---|
| Receipt number | R000070245 |
| Scientific Title | Retrospective Observational Study on the Incidence and Treatment Course of Arrhythmias and Conduction Disturbances in Patients with Cardiac Amyloidosis in Shimane University Hospital |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 22:57:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Retrospective Observational Study on the Incidence and Treatment Course of Arrhythmias and Conduction Disturbances in Patients with Cardiac Amyloidosis in Shimane University Hospital
Acronym
CARHYTHM-S
Scientific Title
Retrospective Observational Study on the Incidence and Treatment Course of Arrhythmias and Conduction Disturbances in Patients with Cardiac Amyloidosis in Shimane University Hospital
Scientific Title:Acronym
CARHYTHM-S
Region
| Japan |
Condition
Condition
Cardiac Amyloidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to elucidate the characteristics of arrhythmias (tachyarrhythmias and bradyarrhythmias) and conduction disturbances occurring in patients with cardiac amyloidosis, and to retrospectively evaluate the clinical course before and after the initiation of disease-modifying therapies, thereby providing insights to inform future management of cardiac amyloidosis.
Basic objectives2
Others
Basic objectives -Others
Descriptive assessment of arrhythmias and conduction disturbances and exploratory analysis of associated factors in cardiac amyloidosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
This study aims to elucidate the clinical characteristics of disease status in patients with AL or transthyretin (ATTR) cardiac amyloidosis, with particular emphasis on arrhythmias (tachyarrhythmias and bradyarrhythmias) and conduction disturbances, and to retrospectively evaluate the clinical course before and after the initiation of disease-modifying therapies, including tafamidis, acoramidis, and vutrisiran.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with cardiac amyloidosis at Shimane University Hospital between January 1, 2020 and January 31, 2026.
2. Patients with confirmed AL or ATTR amyloidosis.
3. Patients who received or were scheduled to receive disease-modifying therapy, including tafamidis, acoramidis, or vutrisiran.
Key exclusion criteria
Patients with concomitant cardiac diseases other than cardiac amyloidosis, such as ischemic heart disease or valvular disease, in whom arrhythmias or conduction disturbances are judged to be clearly attributable to causes other than cardiac amyloidosis.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Furuta |
Organization
Shimane University Faculty of Medicine
Division name
Division of Cardiology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853202249
mdyamag@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Furuta |
Organization
Shimane University Faculty of Medicine
Division name
Cardiology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853202249
Homepage URL
mdyamag@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane, Japan
Tel
0853202515
kenkyu@med.shimane-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
| 2026 | Year | 04 | Month | 27 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data to be collected: patient characteristics, clinical findings, blood and urine test data, physiological test data, imaging data, arrhythmias and their management, treatments other than those for arrhythmias, and clinical outcomes
Management information
Registered date
| 2026 | Year | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070245
