UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062796 |
|---|---|
| Receipt number | R000071889 |
| Scientific Title | Longitudinal Changes in the Relative Apical Sparing Pattern According to Disease Stage in Transthyretin Cardiac Amyloidosis: A Retrospective Observational Study |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/03 00:03:24 |
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Basic information
Public title
Longitudinal Changes in the Relative Apical Sparing Pattern According to Disease Stage in Transthyretin Cardiac Amyloidosis: A Retrospective Observational Study
Acronym
Longitudinal Changes in the Relative Apical Sparing Pattern According to Disease Stage in Transthyretin Cardiac Amyloidosis: A Retrospective Observational Study
Scientific Title
Longitudinal Changes in the Relative Apical Sparing Pattern According to Disease Stage in Transthyretin Cardiac Amyloidosis: A Retrospective Observational Study
Scientific Title:Acronym
Longitudinal Changes in the Relative Apical Sparing Pattern According to Disease Stage in Transthyretin Cardiac Amyloidosis: A Retrospective Observational Study
Region
| Japan |
Condition
Condition
Transthyretin Cardiac Amyloidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate longitudinal changes in the apical sparing pattern and other echocardiographic parameters according to disease progression in patients with transthyretin cardiac amyloidosis (ATTR-CM), and to determine the utility of echocardiography for predicting disease stage and prognosis in patients with cardiac amyloidosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in apical sparing ratio among disease stages
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
Patients diagnosed with transthyretin cardiac amyloidosis (ATTR-CM)
Key exclusion criteria
Patients with inadequate echocardiographic image quality
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Matsumoto |
| Middle name | |
| Last name | Kensuke |
Organization
Kobe University Hospital
Division name
Department of Cardiology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5846
kenmatsu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Matsumoto |
| Middle name | |
| Last name | Kensuke |
Organization
Kobe University Hospital
Division name
Department of Cardiology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5846
Homepage URL
kenmatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
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
Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-5846
kenmatsu@med.kobe-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 | 09 | Month | 10 | 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 | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following parameters will be assessed in patients eligible for observation
Patient characteristics age sex height body weight body surface area BSA body mass index BMI New York Heart Association NYHA functional class medications and comorbidities
Laboratory findings N terminal pro B type natriuretic peptide NT proBNP troponin I estimated glomerular filtration rate eGFR creatinine Cre albumin Alb and hemoglobin Hb
Electrocardiographic findings presence of atrial fibrillation presence of an implanted pacemaker QRS duration PQ interval and presence of low voltage QRS complexes
Echocardiographic findings left ventricular LV mass relative wall thickness left ventricular ejection fraction LVEF global longitudinal strain GLS basal longitudinal strain Basal LS mid ventricular longitudinal strain Mid LS apical longitudinal strain Apical LS relative apical sparing ratio stroke volume cardiac index E A ratio early diastolic mitral annular velocity e E e ratio left atrial volume index LAVI left atrial strain tricuspid annular plane systolic excursion TAPSE fractional area change FAC right ventricular free wall longitudinal strain RV FWLS and right atrial strain
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071889
