Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-05 @ 12:18 AM
Study NCT ID:
NCT01460732
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2011-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers
Sponsor:
Organization:
Raw JSON
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Stergiou', 'organization': 'Hypertension Center, Third University Department of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'description': 'All patients analyzed', 'otherNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}], 'frequencyThreshold': '0.1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Awake Systolic Home Blood Pressure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '131.5', 'spread': '11.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Awake Diastolic Home Blood Pressure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '79.9', 'spread': '7.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Asleep Systolic Home Blood Pressure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '114.8', 'spread': '12.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Asleep Diastolic Home Blood Pressure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '7.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Awake Systolic Ambulatory Blood Pressure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '130.0', 'spread': '11.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': "An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Awake Diastolic Ambulatory Blood Pressure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'spread': '7.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': "An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Asleep Systolic Ambulatory Blood Pressure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '115.2', 'spread': '10.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2weeks', 'description': "An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Asleep Diastolic Ambulatory Blood Pressure Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'spread': '6.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2weeks', 'description': "An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dippers Defined by ABPM and HBPM-Nocturnal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABPM', 'description': 'Dippers defined by ABPM.'}, {'id': 'OG001', 'title': 'HBPM-Nocturnal', 'description': 'Dippers defined by HBPM-Nocturnal.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who had their Daytime and Nocturnal BP assessed by both methods.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'All patients analyzed'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-08', 'studyFirstSubmitDate': '2011-10-25', 'resultsFirstSubmitDate': '2012-02-05', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-01', 'studyFirstPostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Awake Systolic Home Blood Pressure Measurement', 'timeFrame': '2 weeks', 'description': 'Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.'}, {'measure': 'Awake Diastolic Home Blood Pressure Measurement', 'timeFrame': '2 weeks', 'description': 'Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.'}, {'measure': 'Asleep Systolic Home Blood Pressure Measurement', 'timeFrame': '2 weeks', 'description': 'Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.'}, {'measure': 'Asleep Diastolic Home Blood Pressure Measurement', 'timeFrame': '2 weeks', 'description': 'Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.'}, {'measure': 'Awake Systolic Ambulatory Blood Pressure Measurement', 'timeFrame': '2 weeks', 'description': "An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately."}, {'measure': 'Awake Diastolic Ambulatory Blood Pressure Measurement', 'timeFrame': '2 weeks', 'description': "An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately."}, {'measure': 'Asleep Systolic Ambulatory Blood Pressure Measurement', 'timeFrame': '2weeks', 'description': "An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately."}, {'measure': 'Asleep Diastolic Ambulatory Blood Pressure Measurement', 'timeFrame': '2weeks', 'description': "An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately."}], 'secondaryOutcomes': [{'measure': 'Dippers Defined by ABPM and HBPM-Nocturnal', 'timeFrame': '2 weeks', 'description': 'As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Nocturnal BP dipping', 'Home Blood pressure Monitoring', 'Ambulatory Blood Pressure Monitoring'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include:\n\nClinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.', 'detailedDescription': "Eligible patients, as described in Inclusion/Exclusion Criteria, will be instructed to use Microlife WatchBP Home-Nocturnal oscillometric device, in order to measure their BP two times with one-minute interval, in the morning between 6 and 9 am and in the evening between 6 and 9 pm respectively for six days. These six days shall be normal working days, selected be the patient, within a time-frame of two weeks approximately. Patients should be sitting for at least five minutes and calm. During three out of those six days, they will apply and activate the same device, in order to take BP measurements while they will be asleep. Those measurements are going to be taken automatically by the device, the first 2-hours after the activation and another two with one-hour interval. Measurements will be averaged as awake and asleep BP values, with a potential to derive, if so wished, separate averages of awake-morning and awake-evening BP values.\n\nMicrolife WatchBP O3 Ambulatory Blood Pressure Measurement (ABPM) device will be applied by a doctor to each patient and it will be removed the next day by a doctor. BP measurements will be performed every 20 minutes for 24 hours. BP measurements taken during awake and asleep hours for each patient, will be analyzed separately.\n\nAdditionally, triplicate sitting Clinic Blood Pressure measurements, with one-minute interval, will be performed with the Microlife WatchBP Home-Nocturnal device during each patient's visit at the Hypertension Center. Patients will visit Hypertension Center three times, one to apply the ABPM device and one to remove it and provide the Microlife WatchBP Home-Nocturnal device and another one to bring it back. This will take approximately two weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:ma\n\n* Patients referred for high blood pressure\n* Age over 30 years\n* Untreated for hypertension or under stable treatment for 4 weeks or more\n* Patients physically and mentally capable for self-measurement of blood pressure at home\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Sustained arrythmia\n* Pregnancy\n* Symptomatic cardiovascular disease\n* Any other serious disease (renal failure, heart failure, malignancy)'}, 'identificationModule': {'nctId': 'NCT01460732', 'briefTitle': 'Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers', 'orgStudyIdInfo': {'id': 'NOCTURNAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All patients', 'description': 'All eligible patients in the study consist a single group and the same intervention is assigned to all of them.', 'interventionNames': ['Device: Blood Pressure Monitoring']}], 'interventions': [{'name': 'Blood Pressure Monitoring', 'type': 'DEVICE', 'otherNames': ['Microlife WatchBP Home Nocturnal', 'Microlife WatchBP O3'], 'description': 'Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Sotiria General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, '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'}}}}