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NCT Number: NCT02804074

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

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).

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Key information

Conditions

Masked Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optimization of antihypertensive treatment based on office BP

Other

Optimization of antihypertensive treatment based on office BP

Optimization of antihypertensive treatment based on 24-hour ABPM

Other

Optimization of antihypertensive treatment based on 24-hour ABPM

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Zanchetti, MD

CONTACT

[email protected]

+390261911 ext. 2901

Gianfranco Parati, MD

CONTACT

[email protected]

+390261911 ext. 2890

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • European Society of Hypertension

Registry information

Official study title

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

Acronym: MASTER

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2016
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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