Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058923) titled 'Heart failure Early Alert through Remote Telemonitoring - Monitoring and Prediction algorithm' on Sept. 1.
Study Type:
Observational
Primary Sponsor:
Institute - National Cerebral and Cardiovascular Center
Condition:
Condition - heart failure
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 400
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067309
Disclaimer: Curated by HT Syndication.