NCT02804074

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,240 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Masked Hypertension

Interventions

Type	Name	Description
OTHER	Optimization of antihypertensive treatment based on office BP	Optimization of antihypertensive treatment based on office BP
OTHER	Optimization of antihypertensive treatment based on 24-hour ABPM	Optimization of antihypertensive treatment based on 24-hour ABPM

Timeline

• Start date: 2018-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2016-06-17
• Last updated: 2026-03-30

Locations

2 sites across 2 countries: Italy, Venezuela