Clinical Research Directory

Real-World Validation of A Huawei Smartwatch for Hypertension Risk Screening in Malaysia

Background: Hypertension (high blood pressure) is a major risk factor for heart disease and stroke, yet many people do not know they have it. In Malaysia, nearly half of all adults with elevated blood pressure are unaware of their condition. Standard clinic blood pressure checks can miss cases of high blood pressure or falsely flag temporary stress-related spikes. While 24-hour Ambulatory Blood Pressure Monitoring (ABPM) is the standard method for an accurate diagnosis, it is not practical for large-scale screening. Purpose: The purpose of this study is to evaluate whether a novel Huawei smartwatch, which uses photoplethysmography (PPG) technology to estimate blood pressure, can accurately identify individuals at high risk for hypertension in a real-world setting. Study Design \& Procedures: Participants: Approximately 500 adults will be enrolled over a 24-month study period. Screening: All participants will use the Huawei smartwatch screening tool to monitor their blood pressure estimates. Validation: A subgroup of approximately 50 participants identified as high-risk by the smartwatch will undergo 24-hour ABPM (the clinical gold standard) to confirm whether they have high blood pressure. Goal: Researchers aim to validate the accuracy of the smartwatch screening tool against 24-hour ABPM to determine if wearable technology can support early detection and timely treatment of undiagnosed hypertension in the community.

MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement

MASTER study is a 4-year prospective, randomized, open-label, blinded-endpoint study (PROBE) comparing 2 management strategies 1) office BP as a guide to treatment, or 2) 24-hour ABP as a guide to treatment. Study objectives are to investigate whether a management strategy based on out-of-office BP (Ambulatory BP monitoring) versus a management strategy based on office BP measurements is associated with differences in outcome, including cardiovascular and renal intermediate end points at one year; cardiovascular events at 4 years and changes in a number of blood pressure-related variables throughout the study. Patients will be followed-up during the first year focusing on changes in left ventricular mass index (LVMI, co-primary endpoint) and Urinary albumin excretion (UAE, albumin/creatinine ratio, co-primary end-point), and during the whole 48 month period for both changes in LVMI and UAE and events including all-cause mortality, CV morbidity and mortality, cerebral morbidity and mortality.A total of 1240 subjects will be recruited by 30 centers, taking into account a dropout rate of 15% (620 subjects per randomization arm).