UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061220 |
|---|---|
| Receipt number | R000070048 |
| Scientific Title | Observational Registry Study of Wearable Devices in Heart Failure |
| Date of disclosure of the study information | 2026/04/09 |
| Last modified on | 2026/04/09 23:16:02 |
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Basic information
Public title
A study involving people with heart failure, using wearable devices to record their daily lives
Acronym
WEAR-HF
Scientific Title
Observational Registry Study of Wearable Devices in Heart Failure
Scientific Title:Acronym
WEAR-HF
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to establish new clinical indicators for predicting the prognosis of heart failure by analysing various physiological data obtained from digital devices.
Basic objectives2
Others
Basic objectives -Others
The aim is to develop new digital biomarkers and new prognostic indicators for heart failure that integrate clinical information, based on various data obtained from digital devices.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is the occurrence of cardiac events (death, hospitalisation for heart failure, or worsening of heart failure) at week 52.
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
1) Outpatients or inpatients, 4) Participants must have a diagnosis related to heart failure at the time of registration, or a serum NT-proBNP level of 300pg/mL or higher or a BNP level of 100 pg/mL or higher, 3) Participants must have been able to wear the smart band for 24 hours or more.
Key exclusion criteria
1) Patients who have had an assistive artificial heart implanted; 2) Patients deemed unable to attend regular outpatient appointments due to dementia, mental health conditions or similar; 3) Patients deemed unable to wear a smart band.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Shimojima |
Organization
Kanazawa University
Division name
Department of Cardiovascular Medicine
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
0762652254
masaya0322@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Shimojima |
Organization
Kanazawa University
Division name
Department of Cardiovascular Medicine
Zip code
9208641
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
0762652254
Homepage URL
masaya0322@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Masaya Shimojima
Funding Source
Organization
Japan Soceity for promotion of science
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 Ethics Committee of Kanazawa University
Address
13-1 Takaramachi, Kanazawa, Ishikawa
Tel
0762652110
rinri@adm.kanazawa-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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 09 | 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 | 11 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who meet the eligibility criteria and provide written informed consent will be enrolled in this study. Baseline clinical data will be extracted from electronic medical records. Following enrollment, participants will wear a smartwatch for the prospective collection of digital health data, which will be managed and stored in the "Self base" cloud database. At 52 weeks post-enrollment, follow-up examinations including electrocardiography, echocardiography, and clinical data collection will be performed. Cardiovascular events and their specific onset dates will be monitored continuously throughout the study period.
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070048
