Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT06868069
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Blood Pressure Variability and Frailty in the Older People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'At 24 months of follow-up', 'description': 'Adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)'}, {'measure': 'Prevalence of hypotensive phenotype', 'timeFrame': 'At baseline', 'description': 'Hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \\<90 mmHg (or two episodes of daytime SBP \\<90 mmHg, if mean 24 h SBP is \\<125 mmHg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood pressure variability', 'Frailty'], 'conditions': ['Hypertension', 'Old Age']}, 'descriptionModule': {'briefSummary': 'Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \\<90 mmHg (or two episodes of daytime SBP \\<90 mmHg, if mean 24 h SBP is \\<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)', 'detailedDescription': 'Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \\<90 mmHg (or two episodes of daytime SBP \\<90 mmHg, if mean 24 h SBP is \\<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)\n\nSecondary objectives of the study:\n\n* To examine the association between home Blood Pressure Variability (BPV) and frailty, assessed using various tools for assessing frailty\n* To examine the association between short term BPV and adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)\n* To determine the prevalence of hypotensive phenotype according to frailty status in hypertensive individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly hypertensive patients who are enrolled at the Hypertension Centre of Istituto Auxologico italiano IRCCS', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 75 years\n* Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines \\[Williams 2018\\]\n* Consent of the patient (or legal representative) to participate in the study\n\nExclusion Criteria:\n\n* Refusal of the patient or his/her legal representative\n* Life expectancy of less than 6 months'}, 'identificationModule': {'nctId': 'NCT06868069', 'acronym': 'HypoPHrail', 'briefTitle': 'Study on Blood Pressure Variability and Frailty in the Older People', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Study on Blood Pressure Variability and Frailty in the Older People: the HypoPHrail Study', 'orgStudyIdInfo': {'id': '09C409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with hypertension, aged 75 years and older', 'interventionNames': ['Diagnostic Test: Diagnostic tests and questionnaires']}], 'interventions': [{'name': 'Diagnostic tests and questionnaires', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of office blood pressure, orthostatic hypotension, 24-hour ambulatory blood pressure, frailty', 'armGroupLabels': ['Patients with hypertension, aged 75 years and older']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20145', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Croce, MD', 'role': 'CONTACT', 'email': 'a.croce@auxologico.it', 'phone': '+390261911'}], 'facility': 'Istituto Auxologico Italiano IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Alessandro Croce, MD', 'role': 'CONTACT', 'email': 'a.croce@auxologico.it', 'phone': '+3902619111'}, {'name': 'Luca Grappiolo, Dr.', 'role': 'CONTACT', 'email': 'luca.grappiolo@auxologico.it', 'phone': '+3902619111', 'phoneExt': '2894'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}