Condition: Blood Pressure · Heart Disease · Hypertension (HTN) · Sponsor: Biobeat Technologies Ltd.
This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.
This description comes directly from the study's public registry record.
Ruth Caspi-Molad, M.S.c · +972546969474 · ruthie.caspi@bio-beat.com
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| Cardiology, P.C. | Birmingham, Alabama, United States | Recruiting |
| Mayo Clinic | Scottsdale, Arizona, United States | Recruiting |
| Mayo Clinic | Jacksonville, Florida, United States | Recruiting |
| U Health-University of Miami Health System | Miami, Florida, United States | Recruiting |
| Henry Ford Health System | Detroit, Michigan, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| HaEmek Hospital | Afula, Israel | Recruiting |
| The Holy Family Hospital Nazareth | Nazareth, Israel | Recruiting |
| Sheba Medical Center | Ramat Gan, Israel | Recruiting |
| Maccabi Healthcare | Tel Aviv, Israel | Recruiting |
| Instituto Auxologico Italiano | Milan, Italy | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07240831