Compares two ways of adjusting blood pressure medicines in people with masked hypertension
Compares treatment guided by office blood pressure with treatment guided by 24-hour blood pressure monitoring.
Plain-language title generated from the registry record
Registry title: MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement
Key facts
- Where
- Milan, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 80 years old?
Source: NCT02804074, who can take part
Where in Italy
- Istituto Auxologico ItalianoMilan, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituto Auxologico Italiano
- Trial code
- NCT02804074
- Record updated
- 30 March 2026
- Original description
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).Read full original descriptionShow less
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)
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).
Inclusion: 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: Patients in unstable clinical conditions; Known secondary hypertension; Dementia (clinical diagnosis); 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; 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; Hepatic disease as determined by either AST or ALT values > 2 times the upper limit of normal; Orthostatic hypotension (SBP fall > 20 mmHg on standing); Inability or unwillingness to give free informed consent; Pregnancy or planned pregnancy during study period.