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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorIstituto Auxologico Italiano

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female subjects

Age 35-80 years

Ambulatory daytime BP >135/85 mmHg

Ambulatory night-time ABP > 120/70 mmHg

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Optimization of antihypertensive treatment based on office BP

    Other intervention

    Optimization of antihypertensive treatment based on office BP

  • Optimization of antihypertensive treatment based on 24-hour ABPM

    Other intervention

    Optimization of antihypertensive treatment based on 24-hour ABPM

Treatment groups

1,240 Participants
are divided into 2 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

changes in LVMI (co-primary endpoint)

Time frame
12 months
2

UAE (albumin/creatinine ratio, co-primary end-point)

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Istituto Auxologico Italiano

Lead sponsor

European Society of Hypertension

Collaborator