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

Study acronym: MASTER
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Dec 2025 to Dec 2026v13
  2. Notable Primary and study completion dates: Dec 2024 to Dec 2025v12
  3. Notable Primary and study completion dates: Dec 2023 to Dec 2024v11
  4. Minor Re-verified, no change to tracked fieldsv10
  5. Notable Primary completion date: Dec 2021 to Dec 2023
    • Study completion date: Jan 2023 to Dec 2023
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv8
  2. Notable Primary completion date: Jan 2020 to Dec 2021v7
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2018 to Oct 1, 2018
    • Study sites: 1 to 2
    v6
  4. Notable Start date: Feb 2018 to Apr 2018v5
  5. Notable Start date: Sep 2017 to Feb 2018v4
  6. Notable Start date: Jan 2017 to Sep 2017v3
  7. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT02804074
Lead Sponsor Istituto Auxologico Italiano
Collaborators: European Society of Hypertension
Conditions
(from sponsor)
Masked Hypertension
Related terms Masked Hypertension
Enrollment 1,240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov