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Cited by 39Blood Pressure and Hypertension StudiesSodium Intake and HealthCardiovascular Health and Disease Prevention

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

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Parati, Gianfranco, Agabiti-Rosei, Enrico, Bakris, George L, Bilo, Grzegorz, Branzi, Giovanna, Cecchi, Franco, Chrostowska, Marzena, De la Sierra, Alejandro +40 more·2018·BMJ Open
DOI 10.1136/bmjopen-2017-021038PMC PMC6303603
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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.

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Authors
Parati, G., Agabiti-Rosei, E., Bakris, G. L., Bilo, G., Branzi, G., Cecchi, F., Chrostowska, M., De la Sierra, A., Domenech, M., Dorobantu, M., Faria, T., Huo, Y., Jelaković, B., Kahan, T., Konradi, A., Laurent, S., Li, N., Madan, K., Mancia, G., McManus, R. J., Modesti, P. A., Ochoa, J. E., Octavio, J. A., Omboni, S., Palatini, P., Park, J. B., Pellegrini, D., Perl, S., Podoleanu, C., Pucci, G., Redon, J., Renna, N., Rhee, M. Y., Rodilla Sala, E., Sanchez, R., Schmieder, R., Soranna, D., Stergiou, G., Stojanovic, M., Tsioufis, K., Valsecchi, M. G., Veglio, F., Waisman, G. D., Wang, J. G., Wijnmaalen, P., Zambon, A., Zanchetti, A., & Zhang, Y.
Affiliations
  • University of Milan (IT)
  • Department of Medicine, Azienda Spedali Civili di Brescia, Brescia, Italy
  • University of Chicago (US)
  • IRCCS Istituto Auxologico Italiano (IT)
  • University of Florence (IT)
  • Gdańsk Medical University (PL)
  • Department of Internal Medicine, Hospital Mutua Terrassa, University of Barcelona, Barcelona, Spain
  • Department of Cardiovascular, Nutrition and Aging, Hospital Clinic of Barcelona, University of Barcelona, Insitut d’investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain
  • Department of Cardiology, Emergency Clinical Hospital of Bucharest, Bucharest, Romania
  • Peking University First Hospital (CN)
  • University Hospital Centre Zagreb (HR)
  • Danderyds sjukhus (SE)
  • Hypertension Department, Almazov Federeal North-Werst Medical Research Centre, St.Petersburg, Russian Federation
  • Inserm (FR)
  • The Center of Hypertension of the Peoples Hospital, Urumqi, China
  • Sir Ganga Ram Hospital (IN)
  • University of Milano-Bicocca (IT)
  • University of Oxford (GB)
  • Fundacion Venezolana de Hipertensión Arterial, Instituto de investigaciones de Enfermedades Cardiovasculares de LUZ, Maracaibo, Venezuela, Bolivarian Republic of
  • Italian Institute of Telemedicine (IT)
  • University of Padua (IT)
  • JB Lab and Clinic, Seoul, Korea (the Republic of)
  • Medical University of Graz (AT)
  • Universitatea de Medicină, Farmacie, Științe și Tehnologie „George Emil Palade” din Târgu Mureș (RO)
  • University of Perugia (IT)
  • University of Valencia and INCLIVA Research Institute, Valencia, Spain
  • Department of Cardiology, Hospital Español de Mendoza, Mendoza, Argentina
  • Dongguk University Ilsan Hospital (KR)
  • Department of Hypertension, Hospital de Sagunto and University CEU Cardenal Herrera, Ciencias de la Salud, Valencia, Spain
  • Favaloro Foundation (AR)
  • Universitätsklinikum Erlangen (DE)
  • National and Kapodistrian University of Athens (GR)
  • University of Belgrade (RS)
  • Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
  • Department of Internal Medicine, Hypertension Section, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
  • Shanghai Jiao Tong University (CN)
  • Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
Corresponding author
Parati, Gianfranco
ORCID
Venue
BMJ Open
Publisher
BMJ
Published
2018-12
Volume
8
Issue
12
Pages
e021038
ISSN
2044-6055 (ISSN-L)
DOI
10.1136/bmjopen-2017-021038
PMC
PMC6303603
OpenAlex
W2905249240
Cited by
39
References
4
Citations by year
2025: 1 · 2024: 3 · 2023: 4 · 2022: 7 · 2021: 4 · 2020: 12 · 2019: 8
FWCI
4.54
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • BMJ Open (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Americanae (AECID Library) (acceptedVersion, other-oa)
  • HighWire Press Open Archive (acceptedVersion)
  • RECERCAT (Consorci de Serveis Universitaris de Catalunya) (acceptedVersion, cc-by)
  • BOA (University of Milano-Bicocca) (submittedVersion, cc-by-nc)
  • Florence Research (University of Florence) (submittedVersion, cc-by-nc)
  • Dipòsit Digital de la Universitat de Barcelona (Universitat de Barcelona) (submittedVersion, cc-by)
  • LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc-nd)
  • LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc)
  • Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
  • CEU Repositorio Institucional (Fundación Universitaria San Pablo CEU) (submittedVersion, cc-by-nc)
  • Repository of Digital Objects for Teaching Research and Culture (University of Valencia) (submittedVersion, other-oa)
Funders
  • Omron Healthcare Europe B.V.
  • Pfizer Inc.
  • Daiichi Sankyo Co. Ltd
  • Menarini International Operations Luxembourg
  • A&D Engineering, Inc.
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Nursing › Nutrition and Dietetics › Sodium Intake and Health
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
Keywords
ambulatory blood pressure monitoring, office blood pressure measurement, antihypertensive therapy, cardiovascular outcomes, renal outcomes, left ventricular mass, microalbuminuria, cardiovascular events, secondary prevention, treated hypertensive patients, nocturnal blood pressure, daytime blood pressure, 24-hour ambulatory blood pressure, cardiovascular risk stratification
MeSH terms
Albuminuria, Antihypertensive Agents, Echocardiography, Heart Ventricles, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Blood Pressure Monitoring, Ambulatory, Masked Hypertension

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