Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061768) titled 'Clinical Utility of a 24-Hour Home Blood Pressure Management System Using a Novel Sleep Blood Pressure Device' on June 3.
Study Type:
Observational
Primary Sponsor:
Institute - Jichi Medical University School of Medicine
Condition:
Condition - Having cardiovascular risk, or having a blood pressure in the high-normal range (systolic 120-129 mmHg and diastolic less than 80 mmHg) at the most recent health checkup (within the last 6 months)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Targeting adults with cardiovascular risk or with high-normal blood pressure (systolic 120-129 mmHg and diastolic less than 80 mmHg) at their most recent health checkup (within the last six months), this study aims to build and utilize a "24-hour home blood pressure management system." In this study, home blood pressure (morning, daytime, before bedtime, and during sleep) mesured by a portable hoseless sleep home blood pressure monitor (UA-1300BLE) will be monitored at a medical institution. The clinical usefulness and feasibility of implementing this system will be examined by evaluating blood pressure changes over the long term.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Participants must meet all the following criteria:
1) Subjects with one or more cardiovascular risks* or blood pressure at the time of the most recent (within 6 months) blood pressure above high-normal (systolic 120-129 mmHg and diastolic less than 80 mmHg) *Cardiovascular risk: diabetes, hyperlipidemia, hypertension [hypertension under treatment or office blood pressure 130/80 mmHg or more), chronic kidney disease, atrial fibrillation, sleep apnea syndrome, chronic obstructive pulmonary disease, hyperuricemia, current smoking habit, history of cerebrocardiovascular events (stroke, myocardial infarction, angina, aortic dissection, peripheral arterial disease, heart failure)
2) Upper arm circumference: 22.0 cm-32.0 cm
3) Subjects who agree to install a free health care app (A&D Connect Health) for blood pressure measurement and blood pressure data transmission
4) Those who can operate the above app
Key exclusion criteria - 1)Those unfamiliar with the operation of smartphone
2) Smartphone users who do not have an A&D Connect compatible operating system
Target Size - 2000
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 05 Month 29 Day
Date of IRB - 2026 Year 05 Month 29 Day
Anticipated trial start date - 2026 Year 05 Month 29 Day
Last follow-up date - 2035 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070686
Disclaimer: Curated by HT Syndication.
