UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061045 |
|---|---|
| Receipt number | R000069854 |
| Scientific Title | Development and Validation of the Tokyo Heart Score (Provisional) in the Tokyo Comprehensive Support Center for Stroke and Cardiovascular Diseases |
| Date of disclosure of the study information | 2026/03/24 |
| Last modified on | 2026/03/24 21:41:52 |
* 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
Development and Validation of the Tokyo Heart Score (Provisional) within the Tokyo Comprehensive Stroke and Cardiovascular Disease Support Center
Acronym
Tokyo Heart Score Trial
Scientific Title
Development and Validation of the Tokyo Heart Score (Provisional) in the Tokyo Comprehensive Support Center for Stroke and Cardiovascular Diseases
Scientific Title:Acronym
Tokyo Heart Score Study (THSS)
Region
| Japan |
Condition
Condition
Eligible participants are patients receiving outpatient or inpatient care for cardiovascular disease who have been provided with an explanation of the study and have given appropriate informed consent. Cardiovascular conditions include a broad spectrum of heart diseases, including heart failure stages A through D.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a novel, freely available, Japan-specific quality-of-life (QOL) instrument for cardiovascular disease, the Tokyo Heart Score (provisional), as part of the Tokyo Comprehensive Support Center for Stroke and Cardiovascular Diseases model project, and to evaluate its validity and practical utility.
In the validation phase, the Tokyo Heart Score will be assessed in relation to established measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol-5 Dimensions (EQ-5D), as well as completion rates and response burden, to determine its feasibility and applicability in real-world clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the Tokyo Heart Score (provisional) and KCCQ and EQ-5D
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cardiovascular disease under care in a cardiology department who are able to complete the questionnaire.
Key exclusion criteria
- Individuals who do not provide consent to participate in the study, or those deemed inappropriate for participation by the principal investigator.
- No healthy volunteers will be recruited.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
Sakakibara Heart Institute
Division name
Cardiology
Zip code
1830003
Address
Fuchu-City, Asahi-Chou, 3-16-1
TEL
0423143111
st7089-fki@umin.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakayama |
Organization
Sakakibara Heart Institute
Division name
Cardiology
Zip code
1830003
Address
Fuchu-City, Asahi-Chou, 3-16-1
TEL
042-314-3111
Homepage URL
st7089-fki@umin.ac.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Sakakibara Heart Fundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Sakakibara Heart Institute
Address
Fuchu-City, Asahi-Chou, 3-16-1
Tel
0423143111
st7089-fki@umin.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 | 03 | Month | 24 | 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 | 06 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter study
Management information
Registered date
| 2026 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069854
