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

Recruiting · NCT02804074 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Auxologico Italiano

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Hypertension

Interventions studied

Optimization of antihypertensive treatment based on 24-hour ABPMOptimization of antihypertensive treatment based on office BP

What this trial is about

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 can take part

Age range

35 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

2 locations listed.

Fundacion Venezolana de Hipertension Arterial/Instituto de Enfermedades Cardiovasculares de LUZ - Maracaibo, Venezuela
Istituto Auxologico Italiano - Milan, Italy

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →