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

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Masked Hypertension

Treatments: Other: Optimization of antihypertensive treatment based on office BP; Other: Optimization of antihypertensive treatment based on 24-hour ABPM

Study type: Interventional

Funder types: Other

Identifiers

NCT02804074

09A503

Details and patient eligibility

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).

Enrollment: 1,240 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,240 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Management strategy of blood pressure based on office BP as a guide to treatment

Treatment:

Other: Optimization of antihypertensive treatment based on office BP

Group 2

Experimental group

Description:

Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment

Treatment:

Other: Optimization of antihypertensive treatment based on 24-hour ABPM