Tokyo, April 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061220) titled 'A study involving people with heart failure, using wearable devices to record their daily lives' on April 9.
Study Type:
Observational
Primary Sponsor:
Institute - Kanazawa University
Condition:
Condition - Heart Failure
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070048
Disclaimer: Curated by HT Syndication.