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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dc.contributor.authorParati, Gianfranco
dc.contributor.authorAgabiti-Rosei, Enrico
dc.contributor.authorBakris, George L
dc.contributor.authorBilo, Grzegorz
dc.contributor.authorBranzi, Giovanna
dc.contributor.authorCecchi, Franco
dc.contributor.authorChrostowska, Marzena
dc.contributor.authorde la Sierra, Alejandro
dc.contributor.authorDomenech, Monica
dc.contributor.authorDorobantu, Maria
dc.contributor.authorFaria, Thays
dc.contributor.authorHuo, Yong
dc.contributor.authorJelaković, Bojan
dc.contributor.authorKahan, Thomas
dc.contributor.authorKonradi, Alexandra
dc.contributor.authorLaurent, Stéphane
dc.contributor.authorLi, Nanfang
dc.contributor.authorMadan, Kushal
dc.contributor.authorMancia, Giuseppe
dc.contributor.authorMcManus, Richard J
dc.contributor.authorModesti, Pietro Amedeo
dc.contributor.authorOchoa, Juan Eugenio
dc.contributor.authorOctavio, José Andrés
dc.contributor.authorOmboni, Stefano
dc.contributor.authorPalatini, Paolo
dc.contributor.authorPark, Jeong Bae
dc.contributor.authorPellegrini, Dario
dc.contributor.authorPerl, Sabine
dc.contributor.authorPodoleanu, Cristian
dc.contributor.authorPucci, Giacomo
dc.contributor.authorRedon, Josep
dc.contributor.authorRenna, Nicolas
dc.contributor.authorRhee, Moo Yong
dc.contributor.authorRodilla Sala, Enrique
dc.contributor.authorSanchez, Ramiro
dc.contributor.authorSchmieder, Roland
dc.contributor.authorSoranna, Davide
dc.contributor.authorStergiou, George
dc.contributor.authorStojanovic, Milos
dc.contributor.authorTsioufis, Konstantinos
dc.contributor.authorValsecchi, Maria Grazia
dc.contributor.authorVeglio, Franco
dc.contributor.authorWaisman, Gabriel Dario
dc.contributor.authorWang, Ji Guang
dc.contributor.authorWijnmaalen, Paulina
dc.contributor.authorZambon, Antonella
dc.contributor.authorZanchetti, Alberto
dc.contributor.authorZhang, Yuqing
dc.date.accessioned2020-06-08T14:34:49Z
dc.date.available2020-06-08T14:34:49Z
dc.date.issued0000-00-00
dc.description.abstractINTRODUCTION 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 Under140 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
dc.identifier.urihttp://dx.doi.org/10.1136/bmjopen-2017-021038
dc.identifier.urihttps://lib.digitalsquare.io/handle/123456789/64674
dc.relation.uriBMJ open
dc.titleMASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study: a randomised controlled trial protocol.en
dcterms.abstractINTRODUCTION 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 Under140 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
dcterms.contributorParati, Gianfranco
dcterms.contributorAgabiti-Rosei, Enrico
dcterms.contributorBakris, George L
dcterms.contributorBilo, Grzegorz
dcterms.contributorBranzi, Giovanna
dcterms.contributorCecchi, Franco
dcterms.contributorChrostowska, Marzena
dcterms.contributorde la Sierra, Alejandro
dcterms.contributorDomenech, Monica
dcterms.contributorDorobantu, Maria
dcterms.contributorFaria, Thays
dcterms.contributorHuo, Yong
dcterms.contributorJelaković, Bojan
dcterms.contributorKahan, Thomas
dcterms.contributorKonradi, Alexandra
dcterms.contributorLaurent, Stéphane
dcterms.contributorLi, Nanfang
dcterms.contributorMadan, Kushal
dcterms.contributorMancia, Giuseppe
dcterms.contributorMcManus, Richard J
dcterms.contributorModesti, Pietro Amedeo
dcterms.contributorOchoa, Juan Eugenio
dcterms.contributorOctavio, José Andrés
dcterms.contributorOmboni, Stefano
dcterms.contributorPalatini, Paolo
dcterms.contributorPark, Jeong Bae
dcterms.contributorPellegrini, Dario
dcterms.contributorPerl, Sabine
dcterms.contributorPodoleanu, Cristian
dcterms.contributorPucci, Giacomo
dcterms.contributorRedon, Josep
dcterms.contributorRenna, Nicolas
dcterms.contributorRhee, Moo Yong
dcterms.contributorRodilla Sala, Enrique
dcterms.contributorSanchez, Ramiro
dcterms.contributorSchmieder, Roland
dcterms.contributorSoranna, Davide
dcterms.contributorStergiou, George
dcterms.contributorStojanovic, Milos
dcterms.contributorTsioufis, Konstantinos
dcterms.contributorValsecchi, Maria Grazia
dcterms.contributorVeglio, Franco
dcterms.contributorWaisman, Gabriel Dario
dcterms.contributorWang, Ji Guang
dcterms.contributorWijnmaalen, Paulina
dcterms.contributorZambon, Antonella
dcterms.contributorZanchetti, Alberto
dcterms.contributorZhang, Yuqing
dcterms.identifierhttp://dx.doi.org/10.1136/bmjopen-2017-021038
dcterms.relationBMJ open
dcterms.titleMASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study: a randomised controlled trial protocol.en
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