Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 1:02 AM
Study NCT ID:
NCT00841308
Status:
UNKNOWN
Last Update Posted:
2012-05-25
First Post:
2009-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Blood Pressure in Hypertension Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-06-26', 'releaseDate': '2014-05-24'}], 'estimatedResultsFirstSubmitDate': '2014-05-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-24', 'studyFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)', 'timeFrame': 'Baseline and 12 months'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Control, Cost-Effectiveness', 'timeFrame': 'Baseline and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '24152822', 'type': 'DERIVED', 'citation': "Nasothimiou EG, Karpettas N, Dafni MG, Stergiou GS. Patients' preference for ambulatory versus home blood pressure monitoring. J Hum Hypertens. 2014 Apr;28(4):224-9. doi: 10.1038/jhh.2013.104. Epub 2013 Oct 24."}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized study with two arms: the Conventional and Ambulatory blood pressure monitoring arm and the Home blood pressure monitoring arm. The study will include both previously treated and untreated individuals.\n\nBefore randomization and in the end of the study, measurements will be performed using all three blood pressure monitoring methods (Conventional, Ambulatory and Home) as well as assessment of target organ damage (microalbuminuria, electrocardiogram, echocardiogram, carotid-femoral pulse wave velocity and central blood pressure).\n\nThe participants will be randomized into one of the two arms. Diagnosis and titration will be decided according to either Conventional and Ambulatory blood pressure measurements or according to Home blood pressure measurements. Subjects will be followed up for one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Untreated hypertensive adults\n* Treated hypertensive adults with uncontrolled blood pressure\n\nExclusion Criteria:\n\n* Stage III Hypertension\n* Secondary Hypertension\n* Cardiovascular or Renal disease\n* Uncontrolled Diabetes'}, 'identificationModule': {'nctId': 'NCT00841308', 'acronym': 'HBP10', 'briefTitle': 'Home Blood Pressure in Hypertension Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring', 'orgStudyIdInfo': {'id': 'HBP10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'interventionNames': ['Other: Decision to start and titrate drug treatment based only on home blood pressure monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home blood pressure monitoring', 'interventionNames': ['Other: Decision to start and titrate drug treatment based only on home blood pressure monitoring']}], 'interventions': [{'name': 'Decision to start and titrate drug treatment based only on home blood pressure monitoring', 'type': 'OTHER', 'description': 'Drug Treatment according to current Hypertension Guidelines. Decision to start and titrate drug treatment based on clinic and ambulatory blood pressure ("Usual care" arm) versus based on home blood pressure monitoring only ("Home blood pressure monitoring" arm).', 'armGroupLabels': ['Home blood pressure monitoring', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'George S Stergiou, MD', 'role': 'CONTACT', 'email': 'gstergi@med.uoa.gr', 'phone': '+30 210 7763117'}], 'facility': 'Hypertension Center, Third Department of Medicine, University of Athens, Greece', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'George S Stergiou, MD', 'role': 'CONTACT', 'email': 'gstergi@med.uoa.gr', 'phone': '+30 210 7763117'}], 'overallOfficials': [{'name': 'George S Stergiou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hypertension Center, Third Depertment of Medicine, University of Athens, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine and Hypertension', 'investigatorFullName': 'George S. Stergiou', 'investigatorAffiliation': 'University of Athens'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-05-24', 'type': 'RELEASE'}, {'date': '2014-06-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'George S. Stergiou, Associate Professor of Medicine and Hypertension, University of Athens'}}}}