Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT03855605
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2019-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis of Hypertension by Home Blood Pressure Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 470}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2019-02-24', 'studyFirstSubmitQcDate': '2019-02-24', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'validation of the diagnostic algorithm of hypertension', 'timeFrame': 'at baseline', 'description': 'validation of the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement'}], 'secondaryOutcomes': [{'measure': 'the characteristics of patients showing discrepancy of diagnosis', 'timeFrame': 'at baseline', 'description': 'the characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement'}, {'measure': 'the change of diagnostic discrepancy', 'timeFrame': 'from baseline to more than 6 months', 'description': 'the change of diagnostic discrepancy between 24-hour ambulatory blood pressure and home blood pressure measurement during follow up period more than 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension,Essential', 'Home Blood Pressure', 'Ambulatory Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '36517899', 'type': 'DERIVED', 'citation': 'Lee YJ, Rhee MY, Kim JS, Do U, Kim JH, Kim BK, Kim HY. Association of the magnitude of the difference in blood pressure between office and ambulatory measurements with blood pressure variability in untreated individuals. Clin Hypertens. 2022 Dec 15;28(1):36. doi: 10.1186/s40885-022-00220-7.'}]}, 'descriptionModule': {'briefSummary': 'Home blood pressure measurement has been recommended to use in the diagnosis of hypertension. The investigators have developed diagnostic algorithm of hypertension by using 24-hour and home blood pressure measurement. However, the diagnostic agreement between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is about 70 - 85%. The discrepancy of diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure is one of the barriers to introduce home blood pressure measurement in the diagnosis of hypertension.\n\nTo solve the discrepancy, identifying the characteristic patients showing discrepancy of hypertension diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is needed.\n\nThe purpose of the present study are (1) to validate the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement the investigators have developed, and (2) to identifying the characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement, and (3) lastly to improve the diagnostic algorithm of hypertension by using home blood pressure measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'At the out-patient clinics, study investigators recruit study participants who have high blood pressure measured by them at the out-patient clinics and adequate for eligibility.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women\n* Patients with high blood pressure measured by doctors at the outpatient office\n\nExclusion Criteria:\n\n* Patients taking antihypertensive drugs or blood pressure affecting drugs within 1 month\n* Secondary hypertension\n* Hypertensive emergency and urgency\n* Severe heart failure (NYHA III and IV)\n* Angina with 6 months\n* Myocardial infarction within 6 months\n* Peripheral artery disease within 6 months\n* Significant arrhythmia (i.e. ventricular tachycardia and fibrillation, atrial fibrillation, atrial flutter)\n* Pregnancy\n* Night labor, shift worker\n* Those who are currently participating in other clinical studies\n* Those who have taken other clinical trial drugs within the past month\n* According to the opinion of the researcher, those who have or may have a disease that may interfere with the completion of the study\n* History of drug or alcohol dependence within 6 months'}, 'identificationModule': {'nctId': 'NCT03855605', 'briefTitle': 'Diagnosis of Hypertension by Home Blood Pressure Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'DongGuk University'}, 'officialTitle': 'Evaluation of Algorithm for Diagnosis of Hypertension by Home Blood Pressure Monitoring', 'orgStudyIdInfo': {'id': 'DUMC-C1502'}}, 'contactsLocationsModule': {'locations': [{'zip': '10326', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'In order to share the individual participant data, the informed consent from the research participants is required un the Korean law, and we did not get the consent to share at the beginning of this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DongGuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Principal Investigator', 'investigatorFullName': 'Moo-Yong Rhee', 'investigatorAffiliation': 'DongGuk University'}}}}