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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2021
Source National Taiwan University Hospital Hsin-Chu Branch
Contact Hengyu Pan, MD
Phone +886-3-5326151
Email phy20633@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Recent hypertension guidelines stressed the importance of out-of-office BP monitoring. Ambulatory BP (ABPM) and home BP monitoring (HBPM) both predict future cardiovascular events better than office BP. Masked hypertension is an important issue. As revealed by recent studies, daytime BP surge can result in greater target organ damage for high-risk hypertensive individuals. Previous trials such as TASMINH2 and TASMINH-SR study showed positive effects of HBPM on BP control in hypertensive patients. However, several issues preclude perfect applications of HBPM. For example, HBPM could not provide BP recordings during activity or at night-time. In addition, the currently recommended time schedule for HBPM may be insufficient for detecting daytime surge especially among high-risk individuals. Wearable BP devices seem to fill in this gap as a novel approach of out-of-office monitoring. HeartGuide, the new watch BP monitor, was recently validated to provide accurate BP measurements. It could provide incremental knowledge with potentially larger numbers of recordings. The primary objective of this study is to unveil uncontrolled masked hypertension with HeartGuide, particularly for those undetected with current office BP and HBPM. A second objective is to assess diurnal BP trends and BP variability.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Taiwan National Taiwan University Hospital Hsin-chu Branch Hsinchu

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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

Outcome

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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