Study Comparing Blood Pressure Treatment Based on Office Measurements Versus 24-Hour Ambulatory Monitoring in Adults with Masked Hypertension

What this Trial Is About

Researchers are investigating management strategies for masked uncontrolled hypertension to see if using out-of-office blood pressure BP monitoring improves health outcomes compared to office BP measurements. This 4-year, prospective, randomized, open-label, blinded-endpoint study PROBE aims to compare cardiovascular and kidney-related results between these two approaches. The study will recruit 1240 adults aged 35 to 80 years and is sponsored by Istituto Auxologico Italiano. Participants are randomly assigned to one of two groups one using office BP to guide antihypertensive treatment and the other using 24-hour ambulatory BP monitoring ABPM to guide treatment. The study includes a 12-month period focusing on changes in left ventricular mass index LVMI and urinary albumin excretion UAE, with follow-up continuing for a total of 48 months to observe cardiovascular events, mortality, and other health changes. During the study, participants will have their BP management optimized according to their assigned group. Researchers will assess blood pressure-related variables, LVMI, and UAE at one year and monitor cardiovascular and cerebral events through the full 4 years. The study measures these co-primary endpoints at 12 months and collects outcome data on mortality and morbidity over 48 months, ensuring thorough evaluation of each management strategys effects.

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