Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT05781256
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2022-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel BP Monitoring Methods to Study the Association Between Sleep BP Patterns and BP Values in Daily Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2022-06-16', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nocturnal blood pressure fall - wearable validated device', 'timeFrame': '1 week', 'description': 'Average nocturnal blood pressure fall, assessed through a validated wearable device over 7 days'}, {'measure': 'Nocturnal blood pressure fall - ABPM', 'timeFrame': '1 week', 'description': 'Average nocturnal blood pressure fall, assessed through ABPM over 7 days'}], 'secondaryOutcomes': [{'measure': 'Average sleep duration', 'timeFrame': '1 week', 'description': 'Average sleep duration in hours over 7 days, measured by simplified polysomnography'}, {'measure': 'Average systolic and diastolic blood pressure - wearable validated device', 'timeFrame': '1 week', 'description': 'Average systolic and diastolic blood pressure in daily life conditions, assessed through a validated wearable device over 7 days'}, {'measure': 'Average systolic and diastolic blood pressure - ABPM', 'timeFrame': '1 week', 'description': 'Average systolic and diastolic blood pressure in daily life conditions, assessed through ABPM over 7 days'}, {'measure': 'Leptin levels', 'timeFrame': 'At baseline', 'description': 'Leptin levels at baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ambulatory Blood Pressure Monitoring', 'Home Blood Pressure Monitoring', 'Blood Pressure Determination', 'Arterial Hypertension']}, 'descriptionModule': {'briefSummary': "Out-of-office blood pressure (BP) measurement by means of ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) is recommended for the diagnosis and management of hypertension in the latest guidelines. Ambulatory BP values are more strongly associated with target organ damage and cardiovascular (CVD) events than office values. In particular, nocturnal blood pressure level and reduction of BP during the night (dipping) have been recognised as predictors of cardiovascular complications. However, in current clinical practice, these parameters are derived from ABPM. HBPM represents an inexpensive alternative to ABPM, is preferred by patients and provides a more realistic assessment of BP during an individual's daily life. However, until recently, HBPM did not offer the possibility to measure nocturnal BP or dipping.\n\nThe development and validation of new BP devices, such as the NightView (OMRON Healthcare, HEM9601T-E3) could overcome this limitation, offering the possibility of home night-time BP measurements with minimal sleep disturbance. On the other hand the use of wearable devices such as HeartGuide (OMRON Healthcare, HEM-6411T-MAE) could provide BP values in daily life conditions. Compared with conventional HBP, typically measured in resting conditions at home, values obtained with wearable devices might be closer to daytime ABP values.\n\nCombining nocturnal HBP, with daytime BP from wearable device could therefore allow the estimation of dipping status comparable with that provided by ABPM.\n\nIn order to compare HBP-derived dipping estimate with the gold standard ABPM-derived value, it is aimed to enrol patients with hypertension, assess their blood pressure profile with ABPM and provide them with both NightView and HeartGuide devices for 7 days. Then diurnal and nocturnal BP and dipping derived from standard 24-hour ABPM will be compared and the combination of NightView/HeartGuide in order to understand whether the latter can offer a reliable assessment of 24h BP pattern.\n\nFor a better phenotypization of nocturnal BP and dipping status the following determinants of nocturnal BP and dipping status will be also investigated: sleep quality, sleep duration, the presence of sleep disorders, salt consumption, catecholamine phenotype.\n\nThis study will offer the unique opportunity to understand whether such new HBP devices can be offered in alternative to ABPM in the assessment of 24h BP profile in patients with hypertension."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n* \\>18 years old\n* arterial hypertension defined as office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or the presence of antihypertensive treatment\n* antihypertensive treatment stable over 2 weeks preceding enrolment\n* written informed consent\n\nExclusion Criteria:\n\n* atrial fibrillation/flutter of frequent ectopic beats\n* pregnancy and lactation\n* terminal malignant disease, life expectancy \\<6 months\n* limb amputation\n* dementia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* arterial hypertension defined as office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or the presence of antihypertensive treatment\n* antihypertensive treatment stable over 2 weeks preceding enrolment\n* written informed consent\n\nExclusion Criteria:\n\n* atrial fibrillation/flutter of frequent ectopic beats\n* pregnancy and lactation\n* terminal malignant disease, life expectancy \\<6 months\n* limb amputation\n* dementia'}, 'identificationModule': {'nctId': 'NCT05781256', 'acronym': 'CABER-NET', 'briefTitle': 'Novel BP Monitoring Methods to Study the Association Between Sleep BP Patterns and BP Values in Daily Life', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Study on the Association Between Sleep Blood Pressure Patterns and Blood Pressure Values in Daily Life - Usefulness of Novel BP Monitoring Methods', 'orgStudyIdInfo': {'id': '09J902'}}, 'contactsLocationsModule': {'locations': [{'zip': '20149', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Martino Pengo', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Martino Pengo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Auxologico Italiano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}