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MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER)
Gianfranco Parati1,2,3, Enrico Agabiti-Rosei4,5, George L Bakris6,7
1Department of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy.
Insights
Masked uncontrolled hypertension (MUCH) management strategies are compared. The MASTER study assesses whether office or ambulatory blood pressure monitoring better guides treatment for cardiovascular outcomes.
Area of Science:
- Cardiology
- Hypertension Management
- Clinical Trials
Background:
- Masked uncontrolled hypertension (MUCH) increases cardiovascular risk in treated patients.
- Identifying MUCH requires combined office (O) and ambulatory (A) blood pressure (BP) monitoring (M).
- The optimal management strategy for MUCH remains debated.
Purpose of the Study:
- To assess the impact of MUCH management strategies on patient outcomes.
- To compare the effectiveness of office BP monitoring (OBPM) versus ambulatory BP monitoring (ABPM) in guiding MUCH treatment.
- The MASTER study aims to determine the best approach for managing MUCH to reduce cardiovascular complications.
Main Methods:
- A 4-year prospective, randomized, open-label, blinded-endpoint study (MASTER).
- 1240 treated hypertensive patients with MUCH will be randomized.
- Group 1 managed by OBPM; Group 2 managed by ABPM, assessing cardiovascular and renal intermediate outcomes and events.
Main Results:
- This is a pre-results abstract; therefore, main results are not yet available.
- The study is ongoing and will assess changes in left ventricular mass, microalbuminuria, and cardiovascular events.
- Data collection and analysis are in progress to determine the impact of different management strategies.
Conclusions:
- The MASTER study will provide crucial insights into the optimal management of masked uncontrolled hypertension.
- Findings will guide clinical practice regarding the use of OBPM versus ABPM for better cardiovascular risk reduction.
- The study aims to clarify whether ABPM offers superior guidance for antihypertensive treatment adjustments in MUCH patients.
Introduction:
Masked uncontrolled hypertension (MUCH) carries an increased risk of cardiovascular (CV) complications and can be identified through combined use of office (O) and ambulatory (A) blood pressure (BP) monitoring (M) in treated patients. However, it is still debated whether the information carried by ABPM should be considered for MUCH management. Aim of the MASked-unconTrolled hypERtension management based on OBP or on ambulatory blood pressure measurement (MASTER) Study is to assess the impact on outcome of MUCH management based on OBPM or ABPM.
Methods And Analysis:
MASTER is a 4-year prospective, randomised, open-label, blinded-endpoint investigation. A total of 1240 treated hypertensive patients from about 40 secondary care clinical centres worldwide will be included -upon confirming presence of MUCH (repeated on treatment OBP <140/90 mm Hg, and at least one of the following: daytime ABP ≥135/85 mm Hg; night-time ABP ≥120/70 mm Hg; 24 hour ABP ≥130/80 mm Hg), and will be randomised to a management strategy based on OBPM (group 1) or on ABPM (group 2). Patients in group 1 will have OBP measured at 0, 3, 6, 12, 18, 24, 30, 36, 42 and 48 months and taken as a guide for treatment; ABPM will be performed at randomisation and at 12, 24, 36 and 48 months but will not be used to take treatment decisions. Patients randomised to group 2 will have ABPM performed at randomisation and all scheduled visits as a guide to antihypertensive treatment. The effects of MUCH management strategy based on ABPM or on OBPM on CV and renal intermediate outcomes (changing left ventricular mass and microalbuminuria, coprimary outcomes) at 1 year and on CV events at 4 years and on changes in BP-related variables will be assessed.
Ethics And Dissemination:
MASTER study protocol has received approval by the ethical review board of Istituto Auxologico Italiano. The procedures set out in this protocol are in accordance with principles of Declaration of Helsinki and Good Clinical Practice guidelines. Results will be published in accordance with the CONSORT statement in a peer-reviewed scientific journal.
Trial Registration Number:
NCT02804074; Pre-results.
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