6533b85efe1ef96bd12bff00

RESEARCH PRODUCT

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

George L. BakrisMoo Yong RheeRichard J McmanusKonstantinos TsioufisKushal MadanJuan Eugenio OchoaFranco CecchiPaolo PalatiniEnrico Agabiti-roseiDavide SorannaPaulina WijnmaalenRedon JosepAlberto ZanchettiAntonella ZambonRoland E. SchmiederPietro Amedeo ModestiThomas KahanSabine PerlAlejandro De La SierraMaria DorobantuThays FariaMónica DoménechBojan JelakovićGiuseppe ManciaJeong Bae ParkFranco VeglioRamiro A. SanchezGabriel WaismanEnrique RodillaGiovanna BranziStefano OmboniDario PellegriniAlexandra KonradiYuqing ZhangMaria Grazia ValsecchiNanfang LiYong HuoJi-guang WangMarzena ChrostowskaCristian PodoleanuNicolas Federico RennaStéphane LaurentGianfranco ParatiGiacomo PucciMilos StojanovicJosé A. OctavioGeorge S. StergiouGrzegorz Bilo

subject

HYPERTENSION MANAGEMENTHipertensión.1302masked uncontrolled hypertensionEnfermedades cardiovasculares - Pacientes - Factores de riesgo.office blood pressureMASKED UNCONTROLLED HYPERTENSIONMedicina ClínicaCardiovascular Medicine030204 cardiovascular system & hematologyAMBULATORY BLOOD PRESSURE MONITORINGlaw.invention0302 clinical medicineClinical trialsRandomized controlled triallawBlood Pressure MonitoringMasked Hypertension//purl.org/becyt/ford/3.2 [https]ProtocolMulticenter Studies as Topic1506030212 general & internal medicineCardiovascular system - Diseases - Patients - Risk factors.Blood pressure.OFFICE BLOOD PRESSURERandomized Controlled Trials as TopicSistemas Cardíaco y CardiovascularGeneral MedicineBlood Pressure Monitoring Ambulatory3. Good healthCor MalaltiesEchocardiographyAmbulatoryHypertensionBlood pressure//purl.org/becyt/ford/3 [https]Hipertensióambulatory blood pressure monitoring; hypertension; hypertension management; masked uncontrolled hypertension; office blood pressure; treated hypertensive patientsTREATED HYPERTENSIVE PATIENTS1683medicine.medical_specialtyAmbulatory blood pressureCIENCIAS MÉDICAS Y DE LA SALUDhypertensionHeart Ventriclestreated hypertensive patientPressió sanguínia03 medical and health sciencesAmbulatoryHypertension.medicineAlbuminuriaHumansAntihypertensive AgentsProtocol (science)business.industryConsolidated Standards of Reporting Trialsambulatory blood pressure monitoring; hypertension; hypertension management; masked uncontrolled hypertension; office blood pressure; treated hypertensive patients; Albuminuria; Antihypertensive Agents; Echocardiography; Heart Ventricles; Humans; Masked Hypertension; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Blood Pressure Monitoring Ambulatorytreated hypertensive patientsambulatory blood pressure monitoringBlood pressurePresión sanguínea.Good clinical practiceEmergency medicinebusinessDeclaration of Helsinkihypertension managementAssaigs clínics

description

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

yearjournalcountryeditionlanguage
2018-12-01BMJ Open
10.1136/bmjopen-2017-021038http://ora.ox.ac.uk/objects/uuid: