Optimization of antihypertensive treatment based on office BPOptimization of antihypertensive treatment based on 24-hour ABPM
Optimization of antihypertensive treatment based on office BP: Optimization of antihypertensive treatment based on office BP
Optimization of antihypertensive treatment based on 24-hour ABPM: Optimization of antihypertensive treatment based on 24-hour ABPM
Study summary
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
Sex
ALL
Min age
35 Years
Max age
80 Years
Healthy volunteers
No
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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