Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT05247060
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2022-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007024', 'term': 'Hypotension, Orthostatic'}], 'ancestors': [{'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical conditions ( physiological parameters, copatologies) associated with the presence of orthostatic hypotension', 'timeFrame': '4 months', 'description': 'Identification, through a multivariate analysis, of the clinical conditions associated with the presence of orthostatic hypotension in the population of hypertensive patients admitted to Internal Medicine'}], 'secondaryOutcomes': [{'measure': 'Prevalence of orthostatic hypotension', 'timeFrame': '4 months', 'description': 'Prevalence of orthostatic hypotension among hypertensive patients admitted to Internal Medicine'}, {'measure': 'Gender differences in prevalence and conditions associated with orthostatic hypotension', 'timeFrame': '4 months', 'description': 'Assessment of possible gender differences in prevalence and conditions associated with orthostatic hypotension'}, {'measure': 'Level of cognitive impairment of the subjects studied, and relationship with orthostatic hypotension', 'timeFrame': '4 months', 'description': 'Evaluation in the initial visit of the level of cognitive impairment of the subjects studied, and relationship with orthostatic hypotension'}, {'measure': 'Relationship between orthostatic hypotension and a Fragility Index', 'timeFrame': '4 months', 'description': 'Evaluation of the relationship between orthostatic hypotension and a Fragility Index'}, {'measure': 'Relationship between orthostatic hypotension and comorbidity by calculating the index of Charlson comorbidity', 'timeFrame': '4 months', 'description': 'Evaluation of the relationship between orthostatic hypotension and comorbidity by calculating the index of Charlson comorbidity'}, {'measure': 'Prescription drugs on the presence and severity of hypotension Orthostatic', 'timeFrame': '4 months', 'description': 'Analysis of the impact of prescription drugs on the presence and severity of hypotension Orthostatic'}, {'measure': 'Presence of orthostatic hypertension', 'timeFrame': '4 months', 'description': 'Evaluation of the presence of orthostatic hypertension'}, {'measure': 'After 6-12-24-36 months from the index hospitalization, of the state of health of all the subjects evaluated', 'timeFrame': '6-12-24-36 months from hospitalization', 'description': 'Evaluation, after 6-12-24-36 months from the index hospitalization, of the state of health of all the subjects evaluated, reporting the possible onset of falls, major cardiovascular events (stroke, TIA, myocardial infarction, arrhythmias) or death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthostatic hypotension', 'Internal Medicine'], 'conditions': ['Hospitalization']}, 'descriptionModule': {'briefSummary': 'The two scientific societies FADOI and SIIA have decided to start a collaborative study protocol that, through the application of a simple and homogeneous method to diagnose orthostatic hypotension, aims to estimate prevalence, conditions associates and outcomes in a cohort of patients admitted to Internal Medicine Departments and with known or newly diagnosed arterial hypertension.', 'detailedDescription': 'The IP-OP study, is an observational, multicenter, prospective, national study that provides for the involvement of 34 Operating Units of Internal Medicine, and the recording of data relating to 1000 hospitalized adults.\n\nThe clinical data of all consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to take the erect station will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to assume the erect station', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presence of arterial hypertension (known or discovered at hospitalization)\n* Signature of Informed Consent\n\nExclusion Criteria:\n\n* Patients unable to take the standing station for a few minutes'}, 'identificationModule': {'nctId': 'NCT05247060', 'acronym': 'IP-OP', 'briefTitle': 'Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Fadoi Foundation, Italy'}, 'officialTitle': 'Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine - Prevalence, Concomitant Conditions and Outcomes', 'orgStudyIdInfo': {'id': 'FADOI.02.2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertensive Patients Hospitalized in Internal Medicine', 'description': 'Clinical data will be collected from all consecutive patients diagnosed with arterial hypertension hospitalized in Internal Medicine and able to assume the erect station', 'interventionNames': ['Other: no experimental intervention']}], 'interventions': [{'name': 'no experimental intervention', 'type': 'OTHER', 'description': 'There will not be any experimental intervention. The study will be conducted according with normal clinical practice', 'armGroupLabels': ['Hypertensive Patients Hospitalized in Internal Medicine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Legnano', 'state': '(MI)', 'country': 'Italy', 'facility': 'Ospedale Civile', 'geoPoint': {'lat': 45.59788, 'lon': 8.91506}}, {'city': 'Borgo Val di Taro', 'state': '(PR)', 'country': 'Italy', 'facility': 'Ospedale "S. Maria"', 'geoPoint': {'lat': 44.48899, 'lon': 9.76906}}, {'city': 'Luino', 'state': '(VA)', 'country': 'Italy', 'facility': 'Ospedale Luini Confalonieri', 'geoPoint': {'lat': 46.00185, 'lon': 8.74512}}, {'city': 'Bassano del Grappa', 'state': '(VI)', 'country': 'Italy', 'facility': 'P.O. di Rete Bassano', 'geoPoint': {'lat': 45.76656, 'lon': 11.72739}}, {'city': 'Avezzano', 'state': 'AQ', 'country': 'Italy', 'facility': 'P.O. "SS. Filippo e Nicola"', 'geoPoint': {'lat': 42.02896, 'lon': 13.42641}}, {'city': "Cava de' Tirreni", 'state': 'SA', 'country': 'Italy', 'facility': 'Ospedale Civ. "S. Maria Incoronata dell\'Olmo"', 'geoPoint': {'lat': 40.69954, 'lon': 14.70773}}, {'city': 'Chieri', 'state': 'TO', 'country': 'Italy', 'facility': 'Ospedale Maggiore', 'geoPoint': {'lat': 45.01054, 'lon': 7.82133}}, {'city': 'Benevento', 'country': 'Italy', 'facility': "Ospedale di Sant'Agata dei Goti", 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Ospedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Caserta', 'country': 'Italy', 'facility': "AO Sant'Anna e San Sebastiano", 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Ospedale ARNAS Garibaldi', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Como', 'country': 'Italy', 'facility': "Ospedale Sant'Anna", 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'city': 'Cuneo', 'country': 'Italy', 'facility': 'Ospedale di Ceva', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale di Galliera', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'L’Aquila', 'country': 'Italy', 'facility': 'Ospedale San Salvatore', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Luca', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Ospedale Buon Consiglio Fatebenefratelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Ospedale Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'Ospedale di Piove di Sacco', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Pistoia', 'country': 'Italy', 'facility': 'Ospedale San Jacopo', 'geoPoint': {'lat': 43.93064, 'lon': 10.92365}}, {'city': 'Pozzuoli', 'country': 'Italy', 'facility': 'P.O. "S. Maria delle Grazie"', 'geoPoint': {'lat': 40.84394, 'lon': 14.0952}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale Fatebenefratelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rovigo', 'country': 'Italy', 'facility': 'Ospedale Santa Maria della Misericordia', 'geoPoint': {'lat': 45.06982, 'lon': 11.79022}}, {'city': 'Salerno', 'country': 'Italy', 'facility': "AOU San Giovanni di Dio e Ruggi d'Aragona", 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'city': 'Siena', 'country': 'Italy', 'facility': 'Ospedale Abbadia San Salvatore', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Syracuse', 'country': 'Italy', 'facility': 'PO "Umberto I"', 'geoPoint': {'lat': 37.07542, 'lon': 15.28664}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale "Città della Salute"', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Treviso', 'country': 'Italy', 'facility': 'Ospedale Cà Foncello', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'AOUI - Borgo Trento', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Viareggio', 'country': 'Italy', 'facility': 'Ospedale Versilia', 'geoPoint': {'lat': 43.86693, 'lon': 10.2502}}], 'overallOfficials': [{'name': 'Andrea Fontanella, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FADOI FOUNDATION'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fadoi Foundation, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}