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

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.

SUBMITTER: Parati G

PROVIDER: S-EPMC6303603 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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

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

BMJ open 20181219 12

<h4>Introduction</h4>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 ...[more]

PMID: 30573476

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Project description:Background: The epidemic of obesity, along with hypertension (HT) and cardiovascular disease, is a growing contributor to global disease burden. It is postulated that obese children are predisposed to hypertension and subsequent cardiovascular disease in adulthood. Early detection and management of hypertension in these children can significantly modify the course of the disease. However, there is a paucity of studies for the characterization of blood pressure in obese children through ambulatory blood pressure monitoring (ABPM), especially in the developing world. This study aims to characterize ambulatory blood pressure in obese children and to explore feasibility of using office BP that will predict ambulatory hypertension. Methods:In the present study, 55 children with a body mass index (BMI) in the ?95th percentile for age and sex were enrolled in a tertiary care hospital and underwent 24 h of ABPM and detailed biochemical investigations. Results:Ambulatory hypertension was recorded in 14/55 (25.5%; white coat hypertension in 17/29 (58.6%) and masked hypertension in 2/26 (7.69%). For office SBP percentile the area under curve (AUC) was 0.773 (95% CI: 0.619-0.926, p = 0.005) and for office DBP percentile the AUC was 0.802 (95% CI: 0.638-0.966, p = 0.002). The estimated cut offs (Youden's index) for office blood pressure which predicts ambulatory hypertension in obese children were the 93rd percentile for systolic BP (sensitivity-67% and specificity-78%) and the 88th percentile for diastolic BP (sensitivity-83% and specificity-62%). Conclusion:Ambulatory blood pressure abnormalities are highly prevalent among children with obesity. Office blood pressure did not accurately predict ambulatory hypertension. More than half of the children labeled as "hypertension" on office blood pressure measurement in the study were diagnosed to have white coat hypertension (WCH), thus emphasizing the role of ABPM for evaluation of WCH before the child is subjected to detailed investigations or started on pharmacotherapy.

Dataset Information

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

Publications

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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