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

• Autores: Parati, Gianfranco; Agabiti-Rosei, Enrico; Bakris, George L.; Bilo, Grzegorz; Branzi, Giovanna; Cecchi, Franco; Chrostowska, Marzena; De la Sierra, Alejandro; Domenech, Monica; Dorobantu, Maria; Faria, Thays; Huo, Yong; Jelakovic, 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; Renna, Nicolas Federico; Rhee, Moo Yong; Rodilla Sala, Enrique; Sánchez, 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
• Año de publicación: 2018
• Idioma: inglés
• Tipo de recurso: artículo
• Materia: AMBULATORY BLOOD PRESSURE MONITORING; HYPERTENSION; HYPERTENSION MANAGEMENT; MASKED UNCONTROLLED HYPERTENSION; OFFICE BLOOD PRESSURE; TREATED HYPERTENSIVE PATIENTS
• Institución: Consejo Nacional de Investigaciones Científicas y Técnicas

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.
Fil: Parati, Gianfranco. University Of Milan-bicocca, Department Of Medicine; Italia
Fil: Agabiti-Rosei, Enrico. Azienda Spedali Civili Di Brescia, Department Of Medici; Italia
Fil: Bakris, George L.. 4-university Of Chicago, Department Of Medicine; Ash; Estados Unidos
Fil: Bilo, Grzegorz. Irccs Istituto Auxologico Italiano; Italia
Fil: Branzi, Giovanna. Irccs Istituto Auxologico Italiano; Italia
Fil: Cecchi, Franco. Università degli Studi di Firenze; Italia
Fil: Chrostowska, Marzena. Gdanski Uniwersytet Medyczny, ; Rusia
Fil: De la Sierra, Alejandro. Universidad de Barcelona; España
Fil: Domenech, Monica. Universidad de Barcelona; España
Fil: Dorobantu, Maria. Clinical Emergency Hospital Of Bucharest; Rumania
Fil: Faria, Thays. Irccs Istituto Auxologico Italiano; Italia
Fil: Huo, Yong. Peking University; China
Fil: Jelakovic, Bojan. University Of Zagreb School Of Medicine; Croacia
Fil: Kahan, Thomas. Karolinska Huddinge Hospital. Karolinska Institutet;; Suecia
Fil: Konradi, Alexandra. Almazov National Medical Research Centre; Rusia
Fil: Laurent, Stéphane. Universite Paris Descartes; Francia
Fil: Li, Nanfang. Center Of Hypertension Of The Peoples Hospital; China
Fil: Madan, Kushal. Sir Ganga Ram Hospital; India
Fil: Mancia, Giuseppe. University Of Milano - Bicocca; Italia
Fil: McManus, Richard J. University of Oxford;; Reino Unido
Fil: Modesti, Pietro Amedeo. Università degli Studi di Firenze;; Italia
Fil: Ochoa, Juan Eugenio. Irccs Istituto Auxologico Italiano; Italia
Fil: Octavio, José Andrés. Universidad del Zulia;; Venezuela
Fil: Omboni, Stefano. Italian Institute Of Telemedicine, ; Italia
Fil: Palatini, Paolo. Università di Padova; Italia
Fil: Park, Jeong Bae. Jb Lab And Clinic; Corea del Sur
Fil: Pellegrini, Dario. Università di Padova;; Italia
Fil: Perl, Sabine. Medizinische Universität Graz;; Austria
Fil: Podoleanu, Cristian. University Of Medicine And Pharmacy Of Tîrgu Mureș; Rumania
Fil: Renna, Nicolas Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto de Medicina y Biología Experimental de Cuyo; Argentina