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

NCT02804074 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1240

Last updated 2026-03-30

No results posted yet for this study

Summary

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).

Conditions

  • Masked Hypertension

Interventions

OTHER

Optimization of antihypertensive treatment based on office BP

Optimization of antihypertensive treatment based on office BP

OTHER

Optimization of antihypertensive treatment based on 24-hour ABPM

Optimization of antihypertensive treatment based on 24-hour ABPM

Sponsors & Collaborators

  • European Society of Hypertension

    collaborator OTHER

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Gianfranco Parati, MD · Istituto Auxologico Italiano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy
  • Venezuela

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02804074 on ClinicalTrials.gov