MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement

Study Overview
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Brief Summary
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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).

Official Title
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MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)

Conditions
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Masked Hypertension

Intervention / Treatment
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* Other: Optimization of antihypertensive treatment based on office BP
* Other: Optimization of antihypertensive treatment based on 24-hour ABPM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Management strategy of blood pressure based on office BP as a guide to treatment | Other: Optimization of antihypertensive treatment based on office BP<br>* Optimization of antihypertensive treatment based on office BP<br>|
| Experimental: Group 2<br>Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment | Other: Optimization of antihypertensive treatment based on 24-hour ABPM<br>* Optimization of antihypertensive treatment based on 24-hour ABPM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in LVMI (co-primary endpoint) |  | 12 months | 
| UAE (albumin/creatinine ratio, co-primary end-point) |  | 12 months |