About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subjects
Age 35-80 years
Ambulatory daytime BP >135/85 mmHg
Ambulatory night-time ABP > 120/70 mmHg
Disqualifiers
eGFR <45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009), and in particular severe chronic renal failure defined as serum creatinine > 250 umol/l;
Patients in unstable clinical conditions;
Known secondary hypertension;
Orthostatic hypotension (SBP fall > 20 mmHg on standing);
Trial design
Parallel
Treatments tested in this trial
Optimization of antihypertensive treatment based on office BP
Other interventionOptimization of antihypertensive treatment based on office BP
Optimization of antihypertensive treatment based on 24-hour ABPM
Other interventionOptimization of antihypertensive treatment based on 24-hour ABPM
Treatment groups
Trial outcomes
Primary outcomes
changes in LVMI (co-primary endpoint)
UAE (albumin/creatinine ratio, co-primary end-point)
Sponsors and contacts
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Istituto Auxologico Italiano
Lead sponsor
European Society of Hypertension
Collaborator