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BMJ Open. 2018 Dec 19;8(12):e021038. doi: 10.1136/bmjopen-2017-021038.

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

Author information

1
Department of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy.
2
Istituto Auxologico Italiano, IRCCS, Department of Cardiovascular Neural and Metabolic Sciences, San Luca Hospital, Milan, Italy.
3
Centro Interuniversitario di Fisiologia Clinica e Ipertensione, University of Milan, Milan, Italy.
4
Department of Medicine, Azienda Spedali Civili di Brescia, Brescia, Italy.
5
Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
6
Department of Medicine, University of Chicago, Chicago, USA.
7
ASH Comprehensive Hypertension Center, Section of Endocrinology, Diabetes and metabolism, Chicago, USA.
8
Department of Cardiology, Università di Firenze, Florence, Italy.
9
Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland.
10
Department of Internal Medicine, Hospital Mutua Terrassa, University of Barcelona, Barcelona, Spain.
11
Department of Cardiovascular, Nutrition and Aging, Hospital Clinic of Barcelona, University of Barcelona, Insitut d'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
12
Department of Cardiology, Emergency Clinical Hospital of Bucharest, Bucharest, Romania.
13
Department of Cardiology, Peking University First Hospital, Beijing, China.
14
Department of Nephrology, Hypertension, Dialysis and Transplantation, University of Zagreb School of Medicine, University Hospital Center Zagreb, Zagreb, Croatia.
15
Department of Clinical Sciences, Karolinska Institute, Stockholm, Sweden.
16
Division of Cardiovascular Medicine, Danderyd Hospital, Stockholm, Sweden.
17
Hypertension Department, Almazov Federeal North-Werst Medical Research Centre, St.Petersburg, Russian Federation.
18
Departments of Pharmacology, European Georges Pompidou Hospital, Assistance Publique Hôpitaux de Paris, Inserm UMR 970 and University Paris Descartes, Paris, France.
19
The Center of Hypertension of the Peoples Hospital, Urumqi, China.
20
Department of Cardiology, Dharma Vira Heart Center, Sir Ganga Ram Hospital, New Delhi, India.
21
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
22
Department of Medicina Sperimentale e Clinica, University of Florence, Florence, Italy.
23
Fundacion Venezolana de Hipertensión Arterial, Instituto de investigaciones de Enfermedades Cardiovasculares de LUZ, Maracaibo, Venezuela, Bolivarian Republic of.
24
Clinical Research Unit, Italian Institute of Telemedicine, Solbiate Arno, Italy.
25
Dipartimento di Medicina DIMED, University of Padova, Padua, Italy.
26
JB Lab and Clinic, Seoul, Korea (the Republic of).
27
Department of Internal Medicine, Division of Cardiology, Medical University of Graz, Graz, Austria.
28
Department of Cardiology, County Clinical Hospital, University of Medicine and Pharmacy Tirgu Mures, Tirgu Mures, Romania.
29
Department of Medicine, University of Perugia, Perugia, Italy.
30
Hypertension Clinic, Unit of Internal Medicine, "S.Maria" Hospital, Terni, Italy.
31
University of Valencia and INCLIVA Research Institute, Valencia, Spain.
32
Hypertension Clinic, Hospital Clinico de Valencia, Valencia, Spain.
33
Department of Cardiology, Hospital Español de Mendoza, Mendoza, Argentina.
34
Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang-si/Gyeonggi-do, Korea (the Republic of).
35
Department of Hypertension, Hospital de Sagunto and University CEU Cardenal Herrera, Ciencias de la Salud, Valencia, Spain.
36
Metabolic Unit, Hypertension section, Favaloro Foundation, Buenos Aires, Argentina.
37
Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany.
38
Department of Statistics and Quantitative methods, University of Milan-Bicocca, Milan, Italy.
39
School of Medicine, Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, Athens, Greece.
40
Third Department of Medicine, Sotiria Hospital, Athens, Greece.
41
Excellence Centre for Hypertension, Department of Endocrinology, School of Medicine, University of Belgrade, Belgrade, Serbia.
42
First Cardiology Clinic, Medical School, National and Kapodistrian University of Athens, Hippokration Hospital, Athens, Greece.
43
School of Medicine and Surgery, Center of Biostatistics for Clinical Epidemiology, University of Milan-Bicocca, Milan, Italy.
44
Department of Medical Sciences, Internal Medicine and Hypertension Division, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
45
Department of Internal Medicine, Hypertension Section, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
46
School of Medicince, The Shanghai Institute of Hypertension, Ruijin Hospital; Shanghai Jiaotong University, Shanghai, China.
47
Department of Hypertension, Centre For Epidemiological Studies And Clinical Trials, Shanghai Key Laboratory Of Hypertension, Shanghai, China.
48
Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical Colleges, Beijing, China.

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.

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