Heart failure Early Alert through Remote Telemonitoring - Monitoring and Prediction algorithm

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 - HEART-MAP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058923

Enrollment

400

Registered

2025-09-01

Start date

2025-08-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The incidence rate within one year of the following events and their predictive accuracy: - Readmission due to worsening heart failure	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Japan

Contacts

Public ContactChisato Izumi

National Cerebral and Cardiovascular Center Department of Heart Failure and Transplantation

aimgain@ncvc.go.jp0661701070

Outcome results