Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
Study NCT ID:
NCT05304806
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2022-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effective Volemia in Older Adults With Orthostatic Hypotension
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': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of recording during positional echography', 'timeFrame': '3 months', 'description': 'Feasibility of positional echography assessed by\n\n\\- Duration of recording (minutes)'}, {'measure': 'Feasibility of positional echography', 'timeFrame': '3 months', 'description': 'Feasibility of positional echography assessed by\n\n\\- Number of good quality imaging (out of 5 pre specified views : parasternal long axis view, parasternal short axis view, apical views 4 and 5 chamber, subxiphoid view, inferior vena cava view)'}], 'secondaryOutcomes': [{'measure': 'Cardiac ultra sound parameters: left ventricle diastolic diameter', 'timeFrame': '3 months', 'description': '\\- Left ventricle diastolic diameter mm/m2'}, {'measure': 'Cardiac ultra sound parameters: left ventricle ejection fraction', 'timeFrame': '3 months', 'description': '\\- Left ventricle ejection fraction (%)'}, {'measure': 'Cardiac ultra sound parameters: E and A waves velocity', 'timeFrame': '3 months', 'description': '\\- E and A waves velocity (cm/sec) (mitral Doppler)'}, {'measure': 'Cardiac ultra sound parameters: Inferior vena cava size and compliance', 'timeFrame': '3 months', 'description': '\\- Inferior vena cava size (mm) and compliance (%)'}, {'measure': 'Cardiac ultra sound parameters: left atrial size', 'timeFrame': '3 months', 'description': '\\- Left atrial size (cm2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['older', 'orthostatic hypotension', 'volemia', 'clinical sonography'], 'conditions': ['Orthostatic Hypotension']}, 'descriptionModule': {'briefSummary': 'Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults.\n\nThe primary objective of the study is to evaluate feasibility of positional POCUS in aging patients.\n\nThe secondary objectives are to assess the variability of measurements between decubitus and sitting position.', 'detailedDescription': 'This is a monocentric study. Twenty patients will be enrolled, aged of 70 years and older. POCUS parameters, duration of procedure and measurements will be recorded for each patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 70 years, orthostatic hypotension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 70 years and older\n* Orthostatic hypotension or venous insufficiency\n* Affiliated to a social security or beneficiary\n\nExclusion Criteria:\n\n* Refusal to participation to the study\n* Cognitive disorder\n* Unable to keep sitting posture for up to 30 minutes\n* Foreign patients under french AME scheme'}, 'identificationModule': {'nctId': 'NCT05304806', 'acronym': 'EVO', 'briefTitle': 'Effective Volemia in Older Adults With Orthostatic Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effective Volemia in Older Adults With Orthostatic Hypotension, Feasibility Study', 'orgStudyIdInfo': {'id': 'APHP220078'}, 'secondaryIdInfos': [{'id': '2021-A03112-39', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Geriatric medecine department, Ambroise Paré hospital, APHP', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}], 'overallOfficials': [{'name': 'Marion Pepin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geriatric medecine department, Ambroise Paré hospital, APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}