Overview
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
Inclusion Criteria:
- Male and female subjects
- Age 35-80 years
- Masked uncontrolled (in treatment) hypertension: office BP <140/90 mmHg, and one or
more of the following situations:
- Ambulatory daytime BP >135/85 mmHg
- Ambulatory night-time ABP > 120/70 mmHg
- Ambulatory 24h ABP >130/80 mmHg
- eGFR ≥45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009)
Exclusion Criteria:
- 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);
- Dementia (clinical diagnosis);
- Hepatic disease as determined by either AST or ALT values > 2 times the upper limit of normal
- History of gastrointestinal surgery or disorders which could interfere with drug absorption
- Known allergy or contraindications to one of the drugs to be administered in the study
- History of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years
- History of clinically significant autoimmune disorders such as systemic lupus erythematosus.
- History of drug or alcohol abuse within the last 5 years
- History of non-compliance to medical regimens and/or patients who are considered potentially unreliable
- Inability or unwillingness to give free informed consent
- Pregnancy or planned pregnancy during study period.