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Title: MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study: a randomised controlled trial protocol
Author: Parati, Gianfranco
Agabiti-Rosei, Enrico
Bakris, George L.
Bilo, Grzegorz
Branzi, Giovanna
Cecchi, Franco
Chrostowska, Marzena
Sierra, Alejandro de la
Doménech, Mónica
Dorobantu, Maria
Faria, Thays
Huo, Yong
Jelaković, Bojan
Kahan, Thomas
Konradi, Alexandra
Laurent, Stéphane
Li, Nanfang
Madan, Kushal
Mancia, Giuseppe
McManus, Richard J.
Modesti, Pietro Amedeo
Ochoa, Juan Eugenio
Octavio, José Andrés
Omboni, Stefano
Palatini, Paolo
Park, Jeong Bae
Pellegrini, Dario
Perl, Sabine
Podoleanu, Cristian
Pucci, Giacomo
Redon, Josep
Renna, Nicolas
Rhee, Moo Yong
Rodilla Sala, Enrique
Sanchez, Ramiro
Schmieder, Roland
Soranna, Davide
Stergiou, George
Stojanovic, Milos
Tsioufis, Konstantinos
Valsecchi, Maria Grazia
Veglio, Franco
Waisman, Gabriel Dario
Wang, Ji Guang
Wijnmaalen, Paulina
Zambon, Antonella
Zanchetti, Alberto
Zhang, Yuqing
Keywords: Pressió sanguínia
Assaigs clínics
Blood pressure
Clinical trials
Issue Date: 19-Dec-2018
Publisher: BMJ Publishing Group
Abstract: 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.
Note: Reproducció del document publicat a:
It is part of: BMJ Open, 2018, vol. 8, p. e021038
Related resource:
ISSN: 2044-6055
Appears in Collections:Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

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