UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058923 |
|---|---|
| Receipt number | R000067309 |
| Scientific Title | Development of a collaborative platform for building an algorithm and an integrated AI model for early detection of worsening of heart failure through non-invasive remote monitoring |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/29 09:40:33 |
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Basic information
Public title
Heart failure Early Alert through Remote Telemonitoring - Monitoring and Prediction algorithm
Acronym
HEART-MAP
Scientific Title
Development of a collaborative platform for building an algorithm and an integrated AI model for early detection of worsening of heart failure through non-invasive remote monitoring
Scientific Title:Acronym
HEART-MAP
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
- Development of a prediction algorithm using non-invasive devices
- Development of an integrated prediction algorithm using AI
- Implementation of an AI algorithm using a PHR app
Basic objectives2
Others
Basic objectives -Others
- Development of a home biomarker monitoring system
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate within one year of the following events and their predictive accuracy:
- Readmission due to worsening heart failure
Key secondary outcomes
The incidence and prevalence of the following events within one year and their predictive accuracy are evaluated.
1) Intensification of treatment or unplanned outpatient visits due to worsening heart failure (including cases without rehospitalization)
2) A composite endpoint of readmission due to worsening heart failure and all-cause mortality
3) A composite endpoint of readmission due to worsening heart failure and cardiovascular mortality
4) All-cause mortality
5) Cardiovascular mortality
6) Sudden death
7) Occurrence of a 100% increase or 600pg/mL increase in NT-pro BNP from discharge
8) Onset of MCI
9) Prevalence of cognitive impairment
10) Onset of cognitive impairment
11) Prevalence of signs of frailty
12) Onset of signs of frailty
13) Prevalence of IADL (instrumental activities of daily living) impairment
14) Onset of IADL impairment
15) Safety and issue identification of wearable devices
16) Image quality of chest X-rays using low-dose portable X-ray equipment in patients with heart failure
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
- Patients aged 18 years or older at the time of consent
- Patients hospitalized or receiving outpatient treatment with a diagnosis of heart failure, or Taiyo Life insurance policyholders with a history of hospitalization for heart failure
- Patients for whom written consent has been obtained
- Electricity data will be collected from patients who, in principle, live alone (however, patients living with up to four people are also accepted) and are aged 55 years or older at the time of consent.
Key exclusion criteria
- Patients using or planning to use circulatory support (ECMO, LVAD, etc.)
- Patients undergoing dialysis treatment
- Pregnant patients
- Patients with limb disorders or other conditions that make it difficult to wear wearable devices on both wrists
- Patients unable to speak spontaneously
- Patients with obvious dementia (diagnosed with dementia, cognitive impairment severe enough to make it difficult to explain the study, etc.)
- Patients who are otherwise deemed inappropriate for this study by the attending physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Izumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Heart Failure and Transplantation
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka 564-8565, Japan
TEL
0661701070
izumi-ch@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Izumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Heart Failure and Transplantation
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka 564-8565, Japan
TEL
0661701070
Homepage URL
aimgain@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Regional Data Core inc., GPx Japan (General Prognostics), TMS Co., Ltd., (KK) Mediest, Mizuho Bank, Ltd, TAIYO LIFE AGING SOCIETY INSTITUTE, SMK Corporation, TOPPAN Holdings Inc., ICI Inc., TEPCO Power Grid, Inc., Eiken Chemical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center Research Ethics Committee
Address
6-1 Kishibe-Shinmachi, Suita, Osaka 564-8565, Japan
Tel
0661701070
rec-office-ac@ncvc.go.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
国立大学法人 京都大学、国立大学法人 神戸大学、国立大学法人 高知大学、リージョナルデータコア株式会社、株式会社GPx Japan、TMS株式会社、株式会社Mediest、株式会社 みずほ銀行、株式会社太陽生命少子高齢社会研究所、SMK株式会社、TOPPANホールディングス株式会社、ICI株式会社、東京電力パワーグリッド株式会社、栄研科学株式会社
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 01 | 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 | 08 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects who consent will be followed for one year (electrical power data will be for two years).
Patient background, medications, physical examination findings, test results, event information, etc. will be collected at the medical institutions conducting the study, and subjects will be asked to fill out a questionnaire.
Subjects will also be asked to collect healthcare data at home using a smartwatch, record their voice, draw blood at home, and collect power data (electrical power only for subjects aged 55 or older and living with four or fewer people).
This information will be used to develop a predictive algorithm that will enable early detection of worsening heart failure and MCI.
Management information
Registered date
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067309
