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

Gianfranco Parati, Enrico Agabiti-Rosei, George L. Bakris, Grzegorz Bilo, Giovanna Branzi, Franco Cecchi, Marzena Chrostowska, Alejandro De La Sierra, Monica Domenech, Maria Dorobantu, Thays Faria, Yong Huo, Bojan Jelaković, Thomas Kahan, Alexandra Konradi, Stéphane Laurent, Nanfang Li, Kushal Madan, Giuseppe Mancia, Richard J. McManusPietro Amedeo Modesti, Juan Eugenio Ochoa, José Andrés Octavio, Stefano Omboni, Paolo Palatini, Jeong Bae Park, Dario Pellegrini, Sabine Perl, Cristian Podoleanu, Giacomo Pucci, Josep Redon, Nicolas Renna, Moo Yong Rhee, Enrique Rodilla Sala, Ramiro Sanchez, Roland Schmieder, Davide Soranna, George Stergiou, Milos Stojanovic, Konstantinos Tsioufis, Maria Grazia Valsecchi, Franco Veglio, Gabriel Dario Waisman, Ji Guang Wang, Paulina Wijnmaalen, Antonella Zambon, Alberto Zanchetti, Yuqing Zhang

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article numbere021038
JournalBMJ Open
Volume8
Issue number12
DOIs
Publication statusPublished - Dec 1 2018

Fingerprint

Masked Hypertension
Clinical Protocols
Randomized Controlled Trials
Blood Pressure
Random Allocation
Secondary Care Centers
Helsinki Declaration
Ethical Review
Ambulatory Blood Pressure Monitoring
Therapeutics
Practice Guidelines
Ethics
Antihypertensive Agents
Kidney

Keywords

  • ambulatory blood pressure monitoring
  • hypertension
  • hypertension management
  • masked uncontrolled hypertension
  • office blood pressure
  • treated hypertensive patients

ASJC Scopus subject areas

  • Medicine(all)

Cite this

MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study : A randomised controlled trial protocol. / 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; Jelaković, 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; Pucci, Giacomo; Redon, Josep; Renna, Nicolas; Rhee, Moo Yong; Rodilla Sala, Enrique; Sanchez, 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.

In: BMJ Open, Vol. 8, No. 12, e021038, 01.12.2018.

Research output: Contribution to journalArticle

Parati, G, Agabiti-Rosei, E, Bakris, GL, Bilo, G, Branzi, G, Cecchi, F, Chrostowska, M, De La Sierra, A, Domenech, M, Dorobantu, M, Faria, T, Huo, Y, Jelaković, B, Kahan, T, Konradi, A, Laurent, S, Li, N, Madan, K, Mancia, G, McManus, RJ, Modesti, PA, Ochoa, JE, Octavio, JA, Omboni, S, Palatini, P, Park, JB, Pellegrini, D, Perl, S, Podoleanu, C, Pucci, G, Redon, J, Renna, N, Rhee, MY, Rodilla Sala, E, Sanchez, R, Schmieder, R, Soranna, D, Stergiou, G, Stojanovic, M, Tsioufis, K, Valsecchi, MG, Veglio, F, Waisman, GD, Wang, JG, Wijnmaalen, P, Zambon, A, Zanchetti, A & Zhang, Y 2018, 'MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study: A randomised controlled trial protocol', BMJ Open, vol. 8, no. 12, e021038. https://doi.org/10.1136/bmjopen-2017-021038
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 ; Jelaković, 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 ; Pucci, Giacomo ; Redon, Josep ; Renna, Nicolas ; Rhee, Moo Yong ; Rodilla Sala, Enrique ; Sanchez, 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. / MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study : A randomised controlled trial protocol. In: BMJ Open. 2018 ; Vol. 8, No. 12.
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T1 - MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study

T2 - A randomised controlled trial protocol

AU - Parati, Gianfranco

AU - Agabiti-Rosei, Enrico

AU - Bakris, George L.

AU - Bilo, Grzegorz

AU - Branzi, Giovanna

AU - Cecchi, Franco

AU - Chrostowska, Marzena

AU - De La Sierra, Alejandro

AU - Domenech, Monica

AU - Dorobantu, Maria

AU - Faria, Thays

AU - Huo, Yong

AU - Jelaković, Bojan

AU - Kahan, Thomas

AU - Konradi, Alexandra

AU - Laurent, Stéphane

AU - Li, Nanfang

AU - Madan, Kushal

AU - Mancia, Giuseppe

AU - McManus, Richard J.

AU - Modesti, Pietro Amedeo

AU - Ochoa, Juan Eugenio

AU - Octavio, José Andrés

AU - Omboni, Stefano

AU - Palatini, Paolo

AU - Park, Jeong Bae

AU - Pellegrini, Dario

AU - Perl, Sabine

AU - Podoleanu, Cristian

AU - Pucci, Giacomo

AU - Redon, Josep

AU - Renna, Nicolas

AU - Rhee, Moo Yong

AU - Rodilla Sala, Enrique

AU - Sanchez, Ramiro

AU - Schmieder, Roland

AU - Soranna, Davide

AU - Stergiou, George

AU - Stojanovic, Milos

AU - Tsioufis, Konstantinos

AU - Valsecchi, Maria Grazia

AU - Veglio, Franco

AU - Waisman, Gabriel Dario

AU - Wang, Ji Guang

AU - Wijnmaalen, Paulina

AU - Zambon, Antonella

AU - Zanchetti, Alberto

AU - Zhang, Yuqing

PY - 2018/12/1

Y1 - 2018/12/1

N2 - 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.

AB - 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.

KW - ambulatory blood pressure monitoring

KW - hypertension

KW - hypertension management

KW - masked uncontrolled hypertension

KW - office blood pressure

KW - treated hypertensive patients

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