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Essential Manual of 24- Hour Blood Pressure Management Essential Manual of 24-Hour Blood Pressure Management From Morning to Nocturnal Hypertension Second Edition Kazuomi Kario, MD, PhD, FACC, FAHA, FESC Professor and Chairman, Department of Cardiovascular Medicine Jichi Medical University School of Medicine, Tochigi, Japan This edition first published 2022 © 2022 John Wiley & Sons Ltd Edition History John Wiley & Sons Ltd (1e, 2015) All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions. The right of Kazuomi Kario to be identified as the author of this work has been asserted in accordance with law. Registered Offices John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, USA John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial Office 9600 Garsington Road, Oxford, OX4 2DQ, UK For details of our global editorial offices, customer services, and more information about Wiley products visit us at www.wiley.com. Wiley also publishes its books in a variety of electronic formats and by print- on- demand. Some content that appears in standard print versions of this book may not be available in other formats. Limit of Liability/Disclaimer of Warranty The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting scientific method, diagnosis, or treatment by physicians for any particular patient. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Library of Congress Cataloging- in- Publication Data Names: Kario, Kazuomi, author. Title: Essential manual of 24-hour blood pressure management: from morning to nocturnal hypertension / Kazuomi Kario. Other titles: Essential manual of twenty four-hour blood pressure management Description: Second edition. | Hoboken, NJ : Wiley-Blackwell, 2022. | Includes bibliographical references and index. Identifiers: LCCN 2021028709 (print) | LCCN 2021028710 (ebook) | ISBN 9781119799368 (paperback) | ISBN 9781119799382 (adobe pdf) | ISBN 9781119799405 (epub) Subjects: MESH: Hypertension–drug therapy | Blood Pressure Monitoring, Ambulatory | Blood Pressure–physiology | Blood Pressure Determination | Circadian Rhythm–physiology Classification: LCC RC685.H8 (print) | LCC RC685.H8 (ebook) | NLM WG 340 | DDC 616.1/32061–dc23 LC record available at https://lccn.loc.gov/2021028709 LC ebook record available at https://lccn.loc.gov/2021028710 Cover Design: Wiley Cover Images: © Creations/Shutterstock Set in 9/12pt Meridien by Straive, Pondicherry, India 10 9 8 7 6 5 4 3 2 1 Contents Author biography, xi Preface – Direction to “Perfect 24-hour Blood Pressure Control”, xv Acknowledgments, xix 1 Evidence and scientific rationale for ambulatory blood pressure monitoring (ABPM), 1 Diurnal BP variation and the concept of “perfect 24- hour BP control”, 1 Nocturnal hypertension and nocturnal BP dipping status, 3 Nocturnal BP dipping status, 3 Non-dipper patterns of BP and pulse rate, 3 Riser pattern of BP and cardiovascular disease risk, 4 Riser pattern and HF, 7 Riser pattern and brain damage, 15 Nocturnal hypertension, 17 Associated Conditions and Mechanisms of Nocturnal Hypertension, 20 Mechanism of cardiovascular risk of nocturnal hypertension, 22 Extreme dipping, 24 Morning surge in BP, 27 Definition of MBPS, 33 Morning BP surge and cardiovascular disease, 34 Morning BP surge and organ damage, 37 Determinants of MBPS, 43 Mechanism of morning risk, 44 Morning BP surge and hemostatic abnormalities, 46 Vascular mechanism of exaggerated morning BP surge, 49 BP Variability and systemic hemodynamic atherothrombotic syndrome (SHATS), 52 The resonance hypothesis of BP surge, 53 Orthostatic hypertension, 54 Ambulatory BP variability, 57 Visit- to- visit variability in office BP, 58 Vicious cycle between BP variability and vascular disease— SHATS, 59 v vi Contents White- coat and masked hypertension, 71 White- coat hypertension, 73 Masked hypertension, 75 Advances in ABPM, 75 Development of information and communication technology- based multi- sensor (IMS)- ABPM, 75 New ABPM indices, 77 HI- JAMP registry, 82 2 Scientific rationale for HBPM, 85 Five prospective, general practitioner- based, home BP studies, 85 Morning hypertension, 85 Control status of morning home BP in the J- HOP study, 88 Evidence for morning hypertension control, 89 Home BP variability, 99 Morning–evening difference (ME- dif), 99 SD, CV, ARV, and VIM of home BP, 101 Maximum home SBP, 103 Orthostatic Home BP Change, 103 Seasonal variation of home BP and “thermosensitive hypertension”, 109 Alcohol, 113 Daytime hypertension (stress hypertension), 115 Nighttime HBPM, 115 Cutting- edge of HBPM, 115 Basic nighttime home BP monitoring (Medinote), 119 Clinical evidence using nocturnal HBPM: J- HOP nocturnal BP study, 119 Trigger nighttime BP monitoring, 127 IT- based trigger nighttime BP monitoring system and the SPREAD study, 133 CPAP adherence and nighttime BP surge, 135 Antihypertensive medication on nighttime BP surge, 139 Wrist home HBPM and WISDOM Night study, 145 3 Practical use of ABPM and HBPM, 147 Concept and positioning of ABPM and HBPM in guidelines, 147 Recent guidelines, 147 Diagnosis of masked and white- coat hypertension, 147 Definition of morning hypertension, 148 Definition of nocturnal hypertension, 150 When to use HBPM and ABPM, 150 Contents vii Clinically suspected SHATS, 152 Cardio- ankle vascular index (CAVI), 154 Coupling study, 154 How to measure home BP, 155 Nighttime home BP measurement schedule, 159 ABPM parameters, 162 24- hour BP, 166 Daytime BP and nighttime BP, 166 Morning BP parameters, 166 Nighttime BP parameters, 166 MBPS parameters, 166 Nighttime BP surge parameters, 166 Nighttime BP dipping parameters, 167 ABPM- defined hypertension subtypes, 167 Home and ambulatory BP- guided management of hypertension, 167 STEpwise- Personalized 24- hour BP control approach (STEP24 approach), 167 Targeting morning hypertension (Step 1), 167 Targeting nocturnal hypertension (Step 2), 171 Pressor mechanism- based nighttime BP management strategy, 173 4 BP targets, when to initiate antihypertensive therapy, and nonpharmacological treatment, 177 Clinical implications of antihypertensive treatment, 177 SPRINT and automated office BP, 177 Meta- analysis of antihypertensive trials, 177 When to initiate antihypertensive therapy, 178 Patient preference, 178 Sodium intake, 179 Other dietary requirements, 181 Exercise, 183 Sleep hygiene, 185 Housing condition, 185 Applications and algorithms to facilitate lifestyle modification: CureAPP, 187 5 Antihypertensive medication, 189 Concept of 24- hour BP lowering including nighttime and morning BPs, 189 Chronotherapy, 189 Antihypertensive drug choice, 190 Calcium channel blockers, 190 Amlodipine, 194 Nifedipine, 195 viii Contents Cilnidipine, 197 Azelnidipine, 199 Angiotensin- converting enzyme inhibitors, 201 Angiotensin receptor blockers (ARBs), 201 Valsartan, 201 Telmisartan, 204 Candesartan, 204 Olmesartan, 205 Azilsartan, 206 Diuretics, 212 Alpha- adrenergic blockers and beta- adrenergic blockers, 214 Mineralocorticoid receptor blockers (MRB), 215 Angiotensin receptor- neprilysin inhibitor (ARNi), 217 Endothelin receptor antagonists (ERA), 221 Combination therapy, including single pill combinations, 222 First- line therapy, 222 Second- line therapy, 222 Clinical trials of antihypertensive combination therapy, 226 Management of resistant hypertension, 238 Third- line therapy, 238 Fourth- line therapy, 239 SGLT2 inhibitors, 240 SACRA study, 243 SHIFT- J study, 244 LUSCAR study, 248 Summary, 250 Other BP- lowering therapies, 252 Hypnotics, 252 XOR inhibitor, 252 Herbal medication, 253 6 Renal denervation, 255 Unsolved issues in the treatment of hypertension and the era for renal denervation, 255 Hypothesis of perfect 24- hour BP control by renal denervation, 256 History, 257 Advances in devices, 262 Symplicity spyral system (radiofrequency thermal ablation), 262 Iberis® system, 264 Paradise system (ultrasonic thermal ablation), 264 Contents ix Peregrine system (trans- arterial alcohol injection), 265 Other energy modalities, 266 Evidence for renal denervation treatment of hypertension from Sham- controlled trials, 266 SPYRAL trials, 266 RADIANCE- HTN SOLO study, 268 Evidence from Japanese populations, 269 The Global SYMPLICITY Registry (GSR), 269 Safety of the renal denervation procedure, 270 24- hour BP lowering profile for cardiovascular protection, 270 Responders and clinical indications, 272 7 Blood pressure linked telemedicine and telecare, 278 Anticipation medicine, 278 Innovation technology, 280 Concept of “trigger” management, 282 Multisensors and the real- time hybrid Wi- SUN/Wi- Fi transmission system, 283 AI and anticipation models, 284 Development of wearable beat- by- beat (surge) BP monitoring, 285 Surge index, 292 Disaster cardiovascular prevention (DCAP) network, 294 Successful anticipation model of ICT- based BP control, 302 Disaster hypertension, 302 COVID- 19 era, 305 8 Asia perspectives, 311 What is the HOPE Asia Network?, 311 HOPE Asia Network achievements, 312 Characteristics of cardiovascular disease in Asia, 315 Obesity and salt intake in Asia, 315 24- hour ambulatory BP profile in Asia, 320 Asia BP@Home Study, 325 References, 328 Index, 368 Author biography Kazuomi Kario, MD, PhD, FACC, FAHA, FESC Professor Division of Cardiovascular Medicine, Department of Medicine, Center of Excellence, Cardiovascular Research and Development (JCARD), Jichi Medical University School of Medicine; Hypertension Cardiovascular Outcome Prevention and Evidence (HOPE) Asia Network/World Hypertension League 3311- 1, Yakushiji, Shimotsuke, Tochigi 329- 0498, JAPAN Tel: +81- 285- 58- 7538; Fax: +81- 285- 44- 4311; E- mail: [email protected] Professor Kazuomi Kario graduated from Jichi Medical School in 1986. He is currently professor and chairman of cardiovascular medicine, Jichi Medical University School of Medicine, Japan; staff visiting professor, Institute of Cardiovascular Science, University College London, London, UK; visiting professor, Shanghai Jiao Tong University School of Medicine, Shanghai, China; adjunct professor, Yonsei University School of Medicine, Seoul, Korea; and distinguished professor, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. In 2003, Professor Kario and his team were the first to report that the morning surge in blood pressure (BP) was an independent risk factor for cardiovascular disease [1, 2]. He first used “morning hypertension,” defined as morning BP ≥135/85 mmHg, regardless of office BP, and stressed its clinical relevance in his book Clinician’s Manual on Early Morning Risk Management in Hypertension in 2004 (Science Press, London, UK, 2004) [3]. He has also proposed the Resonance hypothesis of BP surge [4], and the concept of systemic hemodynamic atherothrombotic syndrome (SHATS) as a vicious cycle of BP variability and vascular disease [5]. These stress the importance and clinical implications of the perfect 24- hour BP management from morning to nocturnal hypertension concept (2004, 2015, 2018) (Figure 1). xi xii Author biography Kario K, Clinician’sManual on Kario K, Essential Manual of 24- Kario K. EssentialManualon Perfect Early Morning risk Management hour Blood Pressure Management 24-hourBloodPressureManagement in Hypertension, Science Press, from MorningtoNocturnal from MorningtoNocturnal London, UK, pp.1–68,2004 Hypertension, John Wiley& Sons Hypertension. Up-to datefor Ltd.,Oxford,UK, pp.1–138,2015. Anticipation Medicine, WileyPublishing Japan KK, Tokyo, pp.1–309, 2018. Figure 1 Books written by the author. (a) Japan nationwide: 37 prefectures,116 institutes 2009- N=6359 2005- N=4310 2012- N=1496 JMU 2014- Research N=932 Center COUPLING 2021- N=3500 Vascular evaluation system /CAVI2014- (CAVI • Pulse/ECG wave), N=5109 (b) Prospective Cohort study 1. Jichi Medical School ABPM Wave 1 (1992–1998) 2. JHOP (Japan Morning Surge-Home Blood Pressure, 2005–2014) 3. JAMP (Japan Ambulatory Blood Pressure Prospective Study) / HI-JAMP / HI-JAMP-V (2009-) 4. COUPLING (Cardiovascular Prognostic COUPLING Study in Japan, 2015-) 5. WISDOM (Wrist Sleep and CircaDianBlOodPressure Monitoring Program, 2021-) Intervention study 1. JMS-1 (Japan Morning Surge 1, 2003–2005) 2. JMS-TOP (Japan Morning Surge-Total Organ Protection, 2005–2008) 3. HONEST(Home blood pressure measurement with OlmesartanNaive patients to Establish Standard Target blood pressure, 2009–2012) 4. Nocturne (2015–2016) 5. SACRA (SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertension, 2017) 6. REQUIRE (Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension, 2017–2020) 7. HERB DH1 (HERB digital hypertension 1 pivotal, 2018–2019) Figure 2 (a) Jichi Medical University (JMU), Center of Excellence, Community Medicine Cardiovascular Research and Development (JCARD) Network Program Study for Device Development and Evidence. ABPM, ambulatory blood pressure monitoring; CAVI, cardio- ankle vascular index; HBPM, home blood pressure monitoring; ICT, information and communication technology. (b) Jichi Medical University Hypertension Program – Major Clinical Studies.

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