Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863508
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-26
Brief Title:
Wearable Blood Pressure Devices to Identify Masked Uncontrolled Hypertension
Sponsor:
National Taiwan University Hospital Hsin-Chu Branch
Organization:
National Taiwan University Hospital Hsin-Chu Branch
Study Overview
Official Title:
Application of the HeartGuide Blood Pressure Watch Monitor to Identify Masked Uncontrolled Hypertension in Hypertensive Patients With Different Cardiovascular Risks In Taiwan
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 activitysleep 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
HeartGuide provides validated out-of-office BP measurements along with activitysleep 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None