MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study: a randomised controlled trial protocol

Gianfranco Parati, Enrico Agabiti-Rosei, George L Bakris, Grzegorz Bilo, Giovanna Branzi, Franco Cecchi, Marzena Chrostowska, Alejandro De la Sierra, Monica Domenech, Maria Dorobantu, Thays Faria, Yong Huo, Bojan Jelaković, Thomas Kahan, Alexandra Konradi, Stéphane Laurent, Nanfang Li, Kushal Madan, Giuseppe Mancia, Richard J McManus, Pietro Amedeo Modesti, Juan Eugenio Ochoa, José Andrés Octavio, Stefano Omboni, Paolo Palatini, Jeong Bae Park, Dario Pellegrini, Sabine Perl, Cristian Podoleanu, Giacomo Pucci, Josep Redon, Nicolas Renna, Moo Yong Rhee, Enrique Rodilla Sala, Ramiro Sanchez, Roland Schmieder, Davide Soranna, George Stergiou, Milos Stojanovic, Konstantinos Tsioufis, Maria Grazia Valsecchi, Franco Veglio, Gabriel Dario Waisman, Ji Guang Wang, Paulina Wijnmaalen, Antonella Zambon, Alberto Zanchetti, Yuqing Zhang, Gianfranco Parati, Enrico Agabiti-Rosei, George L Bakris, Grzegorz Bilo, Giovanna Branzi, Franco Cecchi, Marzena Chrostowska, Alejandro De la Sierra, Monica Domenech, Maria Dorobantu, Thays Faria, Yong Huo, Bojan Jelaković, Thomas Kahan, Alexandra Konradi, Stéphane Laurent, Nanfang Li, Kushal Madan, Giuseppe Mancia, Richard J McManus, Pietro Amedeo Modesti, Juan Eugenio Ochoa, José Andrés Octavio, Stefano Omboni, Paolo Palatini, Jeong Bae Park, Dario Pellegrini, Sabine Perl, Cristian Podoleanu, Giacomo Pucci, Josep Redon, Nicolas Renna, Moo Yong Rhee, Enrique Rodilla Sala, Ramiro Sanchez, Roland Schmieder, Davide Soranna, George Stergiou, Milos Stojanovic, Konstantinos Tsioufis, Maria Grazia Valsecchi, Franco Veglio, Gabriel Dario Waisman, Ji Guang Wang, Paulina Wijnmaalen, Antonella Zambon, Alberto Zanchetti, Yuqing Zhang

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.

Keywords: ambulatory blood pressure monitoring; hypertension; hypertension management; masked uncontrolled hypertension; office blood pressure; treated hypertensive patients.

Conflict of interest statement

Competing interests: GP: honoraria as lecturer for Pfizer, Daiichi Sankyo, Menarini, Omron Healthcare. EA-R: honoraria and/or support from Menarini, Servier, Recordati,Guidotti,Malesci, Ferrer, DOC gen, Bruno farm. GLB: principal investigator (FIDElio)-Bayer, Steering committee (CREDENCE(Janssen), SONAR (AbbVie)-Consultant for Merck, Relypsa, Vascular Dynamics, Elceyx, Bayer, Janssen, AbbVie. FC: collaboration with Smart Solutions Technologies S.A.; AMICUS; Boston Scientific International S.A . ADS: honoraria as lecturer for Abbott, Daiichi-Sankyo, Lacer, Menarini, and Pfizer. MD: Honoria from Recordati and Servier. TK: Research grants Karolinska Institutet from Amgen, Medtronic, Pfizer, and Record, all outside the presented work. SL: Honoraria for lecturing from Axelife, Daichi-Sankyo, Fukuda-Denshi, Menarini, Novartis, Omron, Servier and Recordati. GM: honoraria aslecturer Actavis, Amgen, Boehringer Ingelheim, CVRx, Daiichi Sankyo, Ferrer, Medtronic, Menarini, Merck, Novartis, Recordati, Sanofi,Servier. RJM: has received BP Monitors forresearch use from Omron. JR: hasbeen paid as lecturer by Daiichi Sankyo, Menarini, BoehringerIngelheim, MSD. MYR: Lecture honoraria from Pfizer,LG Life Sciences, Bayer Korea, Hanmi Pharm. Co., Yuhan Co., Boryung Pharmaceutical Co., Research grant fromBoryung Pharmaceutical Co. and Dong-A Pharmaceutical Co., CJ HealthCare Co. GS: Conductedvalidation studies for various manufacturers; advised manufacturerson device development. JGW: lecture and consulting fees from Bayer, Daiichi-Sankyo, Novartis,Omron, Pfizer, Sanofi, and Servier. AZ: Honoraria from Menarini International.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Randomisation groups and patient flow in the study. ABPM, ambulatory blood pressure monitoring; AHT, antihypertensive treatment; BP, blood pressure.

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