Hypertension,EssentialNCT04863508
Wearable Blood Pressure Devices to Identify Masked Uncontrolled Hypertension.
An observational study of Hypertension,Essential and Hypertension, Masked, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Hypertension,Essential, Hypertension, Masked
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Nov 2020to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants routinely treated at out-patient clinics for hypertension are to be enrolled after informed consent.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-chu Branch
Hsinchu, 300
Hengyu Pan, MD, +886-3-532-6151 ext. 2009, phy20633@gmail.com
About this study
Official title: Application of the HeartGuide Blood Pressure Watch Monitor to Identify Masked Uncontrolled Hypertension in Hypertensive Patients With Different Cardiovascular Risks In Taiwan.
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.
Read the 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.
- Conditions
- Hypertension,Essential, Hypertension, Masked
- Keywords
- home blood pressure monitoring, wearable blood pressure device, masked uncontrolled hypertension
- Medical subject headings
- Essential Hypertension, Masked Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low-risk hypertensive patients | Patients without diabetes, chronic kidney disease, hypertension-mediated organ damage, or established cardiovascular diseases | |
| With-risk hypertensive patients | Patients with diabetes, chronic kidney disease, hypertension-mediated organ damage, but without established cardiovascular diseases | |
| Hypertensive patients with cardiovascular diseases | Patients with established cardiovascular diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of masked uncontrolled hypertension
measured BP>=135/85 mmHg by wearable BP devices or average BP>=130/80 mmHg by ambulatory BP monitor
Measured: during 3-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start26 Nov 2020
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863508
- Sponsor's protocol ID
- 109-029-E
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28834205McManus 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.
PubMed 20619448McManus 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.
PubMed 25157723Kuwabara 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.
PubMed 30609129Pan HY, Lee CK, Liu TY, Lee GW, Chen CW, Wang TD. The role of wearable home blood pressure monitoring in detecting out-of-office control status. Hypertens Res. 2024 Apr;47(4):1033-1041. doi: 10.1038/s41440-023-01539-w.
PubMed 38242946
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the HeartGuide Blood Pressure Watch Monitor to Identify Masked Uncontrolled Hypertension in Hypertensive Patients With Different Cardiovascular Risks In Taiwan.
- ClinicalTrials.gov ID
- NCT04863508
- Acronym / sponsor ID
- 109-029-E
- Conditions
- Hypertension,Essential, Hypertension, Masked
- Keywords
- home blood pressure monitoring, wearable blood pressure device, masked uncontrolled hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-risk hypertensive patients | – | –Patients without diabetes, chronic kidney disease, hypertension-mediated organ damage, or established cardiovascular diseases |
| With-risk hypertensive patients | – | –Patients with diabetes, chronic kidney disease, hypertension-mediated organ damage, but without established cardiovascular diseases |
| Hypertensive patients with cardiovascular diseases | – | –Patients with established cardiovascular diseases |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants routinely treated at out-patient clinics for hypertension are to be enrolled after informed consent.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of masked uncontrolled hypertension
Time frame: during 3-month follow-up period
measured BP>=135/85 mmHg by wearable BP devices or average BP>=130/80 mmHg by ambulatory BP monitor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 28834205Hoshide 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.
- Background: PubMed 20619448McManus 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.
- Background: PubMed 25157723McManus 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.
- Background: PubMed 30609129Kuwabara 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.
- Derived from this study: PubMed 38242946Pan HY, Lee CK, Liu TY, Lee GW, Chen CW, Wang TD. The role of wearable home blood pressure monitoring in detecting out-of-office control status. Hypertens Res. 2024 Apr;47(4):1033-1041. doi: 10.1038/s41440-023-01539-w.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential and Hypertension, Masked, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hengyu Pan, MD (+886-3-5326151 ext. 2009, phy20633@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of masked uncontrolled hypertension (time frame: during 3-month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863508, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.