RECRUITINGINTERVENTIONAL

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)

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 willing to sign a consent form - Pregnancy or planned pregnancy during study period. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

Optimization of antihypertensive treatment based on office BP

OTHER

Optimization of antihypertensive treatment based on 24-hour ABPM

Locations (2)

Istituto Auxologico Italiano

Milan, Italy

Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ

Maracaibo, Venezuela