Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial

Hao-Min Cheng, Shih-Hsien Sung, Chen-Huan Chen, Wen-Chung Yu, Shu-Mei Yang, Chao-Yu Guo, Shao-Yuan Chuang, Chern-En Chiang, Hao-Min Cheng, Shih-Hsien Sung, Chen-Huan Chen, Wen-Chung Yu, Shu-Mei Yang, Chao-Yu Guo, Shao-Yuan Chuang, Chern-En Chiang

Abstract

Background: Home blood pressure (BP) and unattended automated BP (uAOBP) monitoring have been recommended by guidelines for the care of hypertensive subjects. However, BP measurements in the peripheral arteries cannot serve as direct substitutes for their central counterparts. Moreover, the comparative effectiveness and safety of BP-guided strategies using these BP measuring devices have never been evaluated.

Methods/design: Patients with uncontrolled or newly diagnosed hypertension aged 20-90 years will be recruited via outpatient clinics and allocated into three arms by stratified randomization (baseline systolic BP 130-155 mmHg and 155-180 mmHg): home BP, uAOBP, and central BP-guided treatment. At each scheduled visit to the clinic, a patient's BP will be measured by each of the three methods of measuring BP. The blood pressure from three different methods will be confirmed available at each visit. Patients and physicians will be blinded to the allocated interventions because they will use measured BP values in the clinic through a standardized report format. A common BP target for systolic blood pressure (SBP) of 130 mmHg is adopted for these BP-guided strategies. The primary outcome is the change of 24-h mean ambulatory SBP at 3 months. A key secondary outcome is to determine the percentage achieving their target BPs at 3 months and the decrease of left ventricular mass at 12 months.

Discussion: To our knowledge, this is the first prospective double-blind randomized controlled trial to assess the optimal guiding strategy for hypertension. It will help to define which BP monitoring method is the most effective for guiding the clinical management of hypertension. It will provide good evidence to support future guideline recommendations for BP monitoring devices.

Trial registration: ClinicalTrials.gov, NCT03578848 . Registered on 4 June 2018.

Keywords: Blood pressure monitoring; Central blood pressure; Home blood pressure; Sphygmomanometer; Unattended automated office blood pressure.

Conflict of interest statement

Ethics approval and consent to participate

The protocol was approved by the institutional review board at Taipei Veterans General Hospital (2018–05-009A) on 29 May 2018. Informed consent will be obtained from all patients enrolled in the study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of assessment. ABPM ambulatory blood pressure monitoring, BP blood pressure, M month, uAOBP unattended automated BP

References

    1. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R, Prospective Studies C. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360(9349):1903–1913. doi: 10.1016/S0140-6736(02)11911-8.
    1. Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009;338:b1665. doi: 10.1136/bmj.b1665.
    1. Kjeldsen SE, Lund-Johansen P, Nilsson PM, Mancia G. Unattended Blood Pressure Measurements in the Systolic Blood Pressure Intervention Trial: Implications for Entry and Achieved Blood Pressure Values Compared With Other Trials. Hypertension. 2016;67(5):808–812. doi: 10.1161/HYPERTENSIONAHA.116.07257.
    1. Myers MG, Godwin M, Dawes M, Kiss A, Tobe SW, Kaczorowski J. Measurement of blood pressure in the office: recognizing the problem and proposing the solution. Hypertension. 2010;55(2):195–200. doi: 10.1161/HYPERTENSIONAHA.109.141879.
    1. Leung AA, Nerenberg K, Daskalopoulou SS, McBrien K, Zarnke KB, Dasgupta K, Cloutier L, Gelfer M, Lamarre-Cliche M, Milot A, et al. Hypertension Canada's 2016 Canadian Hypertension Education Program Guidelines for Blood Pressure Measurement, Diagnosis, Assessment of Risk, Prevention, and Treatment of Hypertension. Can J Cardiol. 2016;32(5):569–588. doi: 10.1016/j.cjca.2016.02.066.
    1. Whelton PK, Carey RM, Aronow WS, Casey DE, Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018;71(19):2199–2269. doi: 10.1016/j.jacc.2017.11.005.
    1. Task Force Members 2013 ESH/ESC Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) Eur Heart J. 2013;34(28):2159–2219. doi: 10.1093/eurheartj/eht151.
    1. Chiang CE, Wang TD, Ueng KC, Lin TH, Yeh HI, Chen CY, Wu YJ, Tsai WC, Chao TH, Chen CH, et al. 2015 guidelines of the Taiwan Society of Cardiology and the Taiwan Hypertension Society for the management of hypertension. J Chin Med Assoc. 2015;78(1):1–47. doi: 10.1016/j.jcma.2014.11.005.
    1. Fagard RH, Cornelissen VA. Incidence of cardiovascular events in white-coat, masked and sustained hypertension versus true normotension: a meta-analysis. J Hypertens. 2007;25(11):2193–2198. doi: 10.1097/HJH.0b013e3282ef6185.
    1. Bliziotis IA, Destounis A, Stergiou GS. Home versus ambulatory and office blood pressure in predicting target organ damage in hypertension: a systematic review and meta-analysis. J Hypertens. 2012;30(7):1289–99.
    1. Cappuccio FP, Kerry SM, Forbes L, Donald A. Blood pressure control by home monitoring: meta-analysis of randomised trials. BMJ. 2004;329(7458):145. doi: 10.1136/.
    1. Nichols WW, O'Rourke MF, Vlachopoulos C. McDonald’s Blood Flow in Arteries: Theoretic, Experimental and Clinical Principles. 6. London: Arnold; 2011.
    1. Kelly RP, Gibbs HH, O'Rourke MF, Daley JE, Mang K, Morgan JJ, Avolio AP. Nitroglycerin has more favourable effects on left ventricular afterload than apparent from measurement of pressure in a peripheral artery. Eur Heart J. 1990;11(2):138–144. doi: 10.1093/oxfordjournals.eurheartj.a059669.
    1. Sharman JE, Marwick TH, Gilroy D, Otahal P, Abhayaratna WP, Stowasser M. Randomized Trial of Guiding Hypertension Management Using Central Aortic Blood Pressure Compared With Best-Practice Care: Principal Findings of the BP GUIDE Study. Hypertension. 2013;62(6):1138–45.
    1. Cheng HM, Chuang SY, Sung SH, Yu WC, Pearson A, Lakatta EG, Pan WH, Chen CH. Derivation and validation of diagnostic thresholds for central blood pressure measurements based on long-term cardiovascular risks. J Am Coll Cardiol. 2013;62(19):1780–1787. doi: 10.1016/j.jacc.2013.06.029.
    1. Chiang CE, Wang TD, Lin TH, Yeh HI, Liu PY, Cheng HM, Chao TH, Chen CH, Shyu KG, Ueng KC, et al. The 2017 Focused Update of the Guidelines of the Taiwan Society of Cardiology (TSOC) and the Taiwan Hypertension Society (THS) for the Management of Hypertension. Acta Cardiologica Sinica. 2017;33(3):213–225.
    1. Cheng HM, Sung SH, Shih YT, Chuang SY, Yu WC, Chen CH. Measurement accuracy of a stand-alone oscillometric central blood pressure monitor: a validation report for Microlife WatchBP Office Central. Am J Hypertens. 2013;26(1):42–50. doi: 10.1093/ajh/hps021.
    1. World Health Organization. Introduction to Drug Utilization Research. WHO International Working Group for Drug Statistics Methodology, WHO Collaborating Centre for Drug Statistics Methodology, WHO Collaborating Centre for Drug Utilization Research and Clinical Pharmacological Services. ISBN 92 4 156234 X (NLM classification: WB 330); 2003.
    1. Tseng H-M, J-FR L, Tsai YJ. Assessment of health-related quality of life in Taiwan (II): Norming and validation of SF-36 Taiwan version. 2003.
    1. Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–1395. doi: 10.1249/01.MSS.0000078924.61453.FB.
    1. Liou YM, Jwo CJ, Yao KG, Chiang LC, Huang LH. Selection of appropriate Chinese terms to represent intensity and types of physical activity terms for use in the Taiwan version of IPAQ. J Nurs Res. 2008;16(4):252–263. doi: 10.1097/01.JNR.0000387313.20386.0a.
    1. Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999;15(2):116–122. doi: 10.1016/S0899-9007(98)00171-3.
    1. Devereux RB, Alonso DR, Lutas EM, Gottlieb GJ, Campo E, Sachs I, Reichek N. Echocardiographic assessment of left ventricular hypertrophy: comparison to necropsy findings. Am J Cardiol. 1986;57(6):450–458. doi: 10.1016/0002-9149(86)90771-X.
    1. Bella JN, Devereux RB, Roman MJ, O'Grady MJ, Welty TK, Lee ET, Fabsitz R, Howard BV. Relations of left ventricular mass to fat-free and adipose body mass: the strong heart study. The Strong Heart Study Investigators. Circulation. 1998;98(23):2538–2544. doi: 10.1161/01.CIR.98.23.2538.
    1. Lu DY, You LK, Sung SH, Cheng HM, Lin SJ, Chiang FT, Chen CH, Yu WC. Abnormal Pulsatile Hemodynamics in Hypertensive Patients With Normalized 24-Hour Ambulatory Blood Pressure by Combination Therapy of Three or More Antihypertensive Agents. J Clin Hypertens (Greenwich) 2016;18(4):281–289. doi: 10.1111/jch.12751.
    1. Staessen JA, Li Y, Hara A, Asayama K, Dolan E, O'Brien E. Blood Pressure Measurement Anno 2016. Am J Hypertens. 2017;30(5):453–463.
    1. Kaplan NM. Commentary on the sixth report of the Joint National Committee (JNC-6) Am J Hypertens. 1998;11(1 Pt 1):134–136.
    1. Vlachopoulos C, Aznaouridis K, O'Rourke MF, Safar ME, Baou K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with central haemodynamics: a systematic review and meta-analysis. Eur Heart J. 2010;31(15):1865–1871. doi: 10.1093/eurheartj/ehq024.
    1. Cheng HM, Pearson A, Sung SH, Yu WC, Chen CH, Karnon J. Cost-effectiveness of noninvasive central blood pressure monitoring in the diagnosis of hypertension. Am J Hypertens. 2015;28(5):604–614. doi: 10.1093/ajh/hpu214.
    1. Cheng HM, Park S, Huang Q, Hoshide S, Wang JG, Kario K, Park CG, Chen CH. Vascular aging and hypertension: Implications for the clinical application of central blood pressure. Int J Cardiol. 2017;230:209–213. doi: 10.1016/j.ijcard.2016.12.170.
    1. Hodgkinson J, Mant J, Martin U, Guo B, Hobbs FD, Deeks JJ, Heneghan C, Roberts N, McManus RJ. Relative effectiveness of clinic and home blood pressure monitoring compared with ambulatory blood pressure monitoring in diagnosis of hypertension: systematic review. BMJ. 2011;342:d3621. doi: 10.1136/bmj.d3621.
    1. Myers MG. A Short History of Automated Office Blood Pressure - 15 Years to SPRINT. J Clin Hypertens (Greenwich) 2016;18(8):721–724. doi: 10.1111/jch.12820.
    1. Staessen JA, Byttebier G, Buntinx F, Celis H, O'Brien ET, Fagard R. Antihypertensive treatment based on conventional or ambulatory blood pressure measurement. A randomized controlled trial. Ambulatory Blood Pressure Monitoring and Treatment of Hypertension Investigators. JAMA. 1997;278(13):1065–1072. doi: 10.1001/jama.1997.03550130039034.
    1. Staessen JA, Den Hond E, Celis H, Fagard R, Keary L, Vandenhoven G, O'Brien ET. Treatment of Hypertension Based on Home or Office Blood Pressure Trial I: Antihypertensive treatment based on blood pressure measurement at home or in the physician's office: a randomized controlled trial. JAMA. 2004;291(8):955–964. doi: 10.1001/jama.291.8.955.
    1. McManus RJ, Mant J, Haque MS, Bray EP, Bryan S, Greenfield SM, Jones MI, Jowett S, Little P, Penaloza C, et al. Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. JAMA. 2014;312(8):799–808. doi: 10.1001/jama.2014.10057.
    1. Group SR. Wright JT, Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, et al. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015;373(22):2103–2116. doi: 10.1056/NEJMoa1511939.
    1. Sharman JE, Avolio AP, Baulmann J, Benetos A, Blacher J, Blizzard CL, Boutouyrie P, Chen CH, Chowienczyk P, Cockcroft JR, et al. Validation of non-invasive central blood pressure devices: ARTERY Society task force consensus statement on protocol standardization. Eur Heart J. 2017;38(37):2805–2812. doi: 10.1093/eurheartj/ehw632.
    1. Chuang SY, Chang HY, Cheng HM, Pan WH, Chen CH. Prevalence of Hypertension Defined by Central Blood Pressure Measured Using a Type II Device in a Nationally Representative Cohort. Am J Hypertens. 2018;31(3):346–354. doi: 10.1093/ajh/hpx178.

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