Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:39 PM
Study NCT ID:
NCT04863508
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Blood Pressure Devices to Identify Masked Uncontrolled Hypertension.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D059468', 'term': 'Masked Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Newly diagnosed left ventricular hypertrophy by echocardiography', 'timeFrame': 'at 3-month follow-up', 'description': 'left ventricular mass index\\>=115 g/m2(men) or \\>=95 g/m2(women)'}, {'measure': 'Occurrence of post-prandial BP change', 'timeFrame': 'during 3-month follow-up period', 'description': 'measured BP drop \\>= 20 mmHg pre- and post-meal'}, {'measure': 'BP variability', 'timeFrame': 'during 3-month follow-up period', 'description': 'coefficient of variation of all measured BP values by either HeartGuide or ambulatory BP monitor'}], 'primaryOutcomes': [{'measure': 'Occurrence of masked uncontrolled hypertension', 'timeFrame': 'during 3-month follow-up period', 'description': 'measured BP\\>=135/85 mmHg by wearable BP devices or average BP\\>=130/80 mmHg by ambulatory BP monitor'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['home blood pressure monitoring', 'wearable blood pressure device', 'masked uncontrolled hypertension'], 'conditions': ['Hypertension,Essential', 'Hypertension, Masked']}, 'referencesModule': {'references': [{'pmid': '28834205', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20619448', 'type': 'BACKGROUND', '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.'}, {'pmid': '25157723', 'type': 'BACKGROUND', '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.'}, {'pmid': '30609129', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHeartGuide 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.', 'detailedDescription': '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.\n\nPrevious 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.\n\nHeartGuide, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants routinely treated at out-patient clinics for hypertension are to be enrolled after informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to sign informed consent form\n* Currently taking anti-hypertensive therapy for more than 3 months\n* Drugs are unchanged during the study period\n* Office BP below 140/90 mmHg at least one visit\n\nExclusion Criteria:\n\n* Diagnosed with terminal illness\n* End-stage renal disease requiring lifelong dialysis treatment\n* Patients with impaired performance status (ECOG \\>= 2)\n* Women undergoing or expecting pregnancy during the study period\n* Resistant hypertension (taking more than 4 kinds of anti-hypertensive drugs)\n* Known atrial or ventricular arrhythmia\n* Wrist circumference out-of range between 13.5 to 21.5 cm'}, 'identificationModule': {'nctId': 'NCT04863508', 'briefTitle': 'Wearable Blood Pressure Devices to Identify Masked Uncontrolled Hypertension.', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital Hsin-Chu Branch'}, 'officialTitle': 'Application of the HeartGuide Blood Pressure Watch Monitor to Identify Masked Uncontrolled Hypertension in Hypertensive Patients With Different Cardiovascular Risks In Taiwan.', 'orgStudyIdInfo': {'id': '109-029-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low-risk hypertensive patients', 'description': 'Patients without diabetes, chronic kidney disease, hypertension-mediated organ damage, or established cardiovascular diseases'}, {'label': 'With-risk hypertensive patients', 'description': 'Patients with diabetes, chronic kidney disease, hypertension-mediated organ damage, but without established cardiovascular diseases'}, {'label': 'Hypertensive patients with cardiovascular diseases', 'description': 'Patients with established cardiovascular diseases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '300', 'city': 'Hsinchu', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hengyu Pan, MD', 'role': 'CONTACT', 'email': 'phy20633@gmail.com', 'phone': '+886-3-532-6151', 'phoneExt': '2009'}], 'facility': 'National Taiwan University Hospital Hsin-chu Branch', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}], 'centralContacts': [{'name': 'Hengyu Pan, MD', 'role': 'CONTACT', 'email': 'phy20633@gmail.com', 'phone': '+886-3-5326151', 'phoneExt': '2009'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital Hsin-Chu Branch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}