Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT05776394
Status:
UNKNOWN
Last Update Posted:
2023-03-20
First Post:
2023-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Hypertension and Frailty in the Older People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daytime systolic blood pressure variability', 'timeFrame': 'At baseline', 'description': 'Standard deviation of daytime systolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Nighttime systolic blood pressure variability', 'timeFrame': 'At baseline', 'description': 'Standard deviation of nighttime systolic blood pressure'}, {'measure': '24h systolic blood pressure variability', 'timeFrame': 'At baseline', 'description': 'Standard deviation of 24h systolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty', 'High Blood Pressure']}, 'descriptionModule': {'briefSummary': "To estimate the linear association between daytime systolic blood pressure variability evaluated as standard deviation (SD) and frailty evaluated as Frailty index according to the Rockwood's accumulation of deficits model"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines\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': 'NCT05776394', 'acronym': 'HYPER-FRAIL', 'briefTitle': 'Study on Hypertension and Frailty in the Older People', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Study on Hypertension and Frailty in the Older People: the HYPER-FRAIL Study', 'orgStudyIdInfo': {'id': '09C214'}}, 'contactsLocationsModule': {'locations': [{'zip': '28145', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Croce Alessandro, MD', 'role': 'CONTACT', 'email': 'a.croce@auxologico.it', 'phone': '+3961911', 'phoneExt': '2830'}], 'facility': 'Ospedale San Luca', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Alessandro IT Croce, MD', 'role': 'CONTACT', 'email': 'a.croce@auxologico.it', 'phone': '0261911', 'phoneExt': '2730'}, {'name': 'Martino IT Pengo, PhD', 'role': 'CONTACT', 'email': 'm.pengo@auxologico.it'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}