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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,240
Optimization of antihypertensive treatment based on office BP
Optimization of antihypertensive treatment based on 24-hour ABPM
Istituto Auxologico Italiano
Milan, Italy
NOT_YET_RECRUITINGFundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ
Maracaibo, Venezuela
RECRUITINGchanges in LVMI (co-primary endpoint)
Time frame: 12 months
UAE (albumin/creatinine ratio, co-primary end-point)
Time frame: 12 months
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