Hypertension,Essential Clinical Trial
Official title:
Application of the HeartGuide Blood Pressure Watch Monitor to Identify Masked Uncontrolled Hypertension in Hypertensive Patients With Different Cardiovascular Risks In Taiwan.
NCT number | NCT04863508 |
Other study ID # | 109-029-E |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 26, 2020 |
Est. completion date | October 2021 |
Uncontrolled out-of-office blood pressure (BP), measured by either home BP monitoring (HBPM) or ambulatory BP monitoring, has been shown to predict higher cardiovascular risk. However, HBPM could not identify daytime BP surge, which leads to underestimation of future risk among treated hypertensive individuals. HeartGuide provides validated out-of-office BP measurements, along with activity/sleep recordings. The present study is designed to examine whether BP monitoring with the HeartGuide could identify masked uncontrolled hypertension in controlled hypertensive patients based on office BP. We will enroll hypertensive patients with controlled office BP according to their cardiovascular risk profile. We will also examine prevalence of post-prandial BP changes and BP variability using HeartGuide.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | October 2021 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 85 Years |
Eligibility | Inclusion Criteria: - Willing to sign informed consent form - Currently taking anti-hypertensive therapy for more than 3 months - Drugs are unchanged during the study period - Office BP below 140/90 mmHg at least one visit Exclusion Criteria: - Diagnosed with terminal illness - End-stage renal disease requiring lifelong dialysis treatment - Patients with impaired performance status (ECOG >= 2) - Women undergoing or expecting pregnancy during the study period - Resistant hypertension (taking more than 4 kinds of anti-hypertensive drugs) - Known atrial or ventricular arrhythmia - Wrist circumference out-of range between 13.5 to 21.5 cm |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital Hsin-chu Branch | Hsinchu |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital Hsin-Chu Branch |
Taiwan,
Hoshide S, Cheng HM, Huang Q, Park S, Park CG, Chen CH, Wang JG, Kario K; Characteristics On the ManagEment of Hypertension in Asia - Morning Hypertension Discussion Group (COME Asia MHDG). Role of ambulatory blood pressure monitoring for the management of hypertension in Asian populations. J Clin Hypertens (Greenwich). 2017 Dec;19(12):1240-1245. doi: 10.1111/jch.13086. Epub 2017 Aug 22. Review. — View Citation
Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of a wrist-type home nocturnal blood pressure monitor in the sitting and supine position according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-9600T. J Clin Hypertens (Greenwich). 2019 Apr;21(4):463-469. doi: 10.1111/jch.13464. Epub 2019 Jan 4. — View Citation
McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Banting M, Bryan S, Little P, Williams B, Hobbs FD. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet. 2010 Jul 17;376(9736):163-72. doi: 10.1016/S0140-6736(10)60964-6. Epub 2010 Jul 8. — View Citation
McManus RJ, Mant J, Haque MS, Bray EP, Bryan S, Greenfield SM, Jones MI, Jowett S, Little P, Penaloza C, Schwartz C, Shackleford H, Shovelton C, Varghese J, Williams B, Hobbs FD, Gooding T, Morrey I, Fisher C, Buckley D. 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 Aug 27;312(8):799-808. doi: 10.1001/jama.2014.10057. Erratum in: JAMA. 2014 Nov 26;312(20):2169. Gooding, Trevor [Added]; Morrey, Ian [Added]; Fisher, Crispin [Added]; Buckley, David [Added]. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Newly diagnosed left ventricular hypertrophy by echocardiography | left ventricular mass index>=115 g/m2(men) or >=95 g/m2(women) | at 3-month follow-up | |
Other | Occurrence of post-prandial BP change | measured BP drop >= 20 mmHg pre- and post-meal | during 3-month follow-up period | |
Other | BP variability | coefficient of variation of all measured BP values by either HeartGuide or ambulatory BP monitor | during 3-month follow-up period | |
Primary | Occurrence of masked uncontrolled hypertension | measured BP>=135/85 mmHg by wearable BP devices or average BP>=130/80 mmHg by ambulatory BP monitor | during 3-month follow-up period |
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