Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-04 @ 1:26 AM
Study NCT ID:
NCT06190756
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2023-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Gravity on Cardiac Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D018475', 'term': 'Head-Down Tilt'}, {'id': 'D008150', 'term': 'Lower Body Negative Pressure'}], 'ancestors': [{'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D003664', 'term': 'Decompression'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison of two groups : Control vs. Diabetes'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rythme', 'timeFrame': 'baseline, during the intervention', 'description': 'continuous electrocardiogram monitoring for assessing the variation of heart frequency'}, {'measure': 'Arterial blood pressure', 'timeFrame': 'baseline, during the intervention', 'description': 'continuous central arterial pressure monitoring using Finapress'}, {'measure': 'thoracic Impedancemetry', 'timeFrame': 'baseline, during the intervention', 'description': 'estimation of body fluid variation as a surrogate of prelaod'}, {'measure': 'Echocardiography', 'timeFrame': 'baseline, during the intervention', 'description': 'non invasive diastolic intraventricular pressure gradient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gravity', 'Intracardiac pressure gradients', 'Cardiac function', 'Echocardiography', 'Lower Body Negative Pressure', 'Tilt-test', 'Diabetes', 'Color Doppler M mode'], 'conditions': ['Diabetes type1', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to define and compare pre-load dependance of the cardiac function according to the intracardiac hydrostatic gradient of pressure in healthy and diabetic populations.\n\nParticipants will undergo 4 tilt angle and 4 lower body negative pressure intensities during which cardiovascular data will be assessed and a transthoracic echography will be performed.', 'detailedDescription': 'Gravitational force affects both the cardiac mass and the thoracic compartment. However, few studies in humans have explored whether the relationship between cardiac function and load-dependence varies according to the orientation of the heart in space (e.g. between the upright and supine positions) and therefore according to gravitational stress.\n\nThirty-two volunteers (16 healthy subjects and 16 subjects with type I diabetes) will be included in the study. Each subject will be analysed over half a day in the Inserm COMETE laboratory. Measurements of the intra-cardiac hydrostatic pressure gradient (reflecting gravitational force) and indicators of cardiac function will be analysed by transthoracic echocardiography using dedicated post-processing software. These measurements will be compared at identical pre-load on the basis of the relationship between thoracic impedance and angle of vertical inclination using a Tilt Test on the one hand and between thoracic impedance and Lower Body Negative Pressure (LBNP) depression in the supine position on the other. In the supine position, the echocardiogram will be repeated for each subject with different levels of intensity of preload decrease by LBNP up to a maximum of -50 torr, and compared with different angles of vertical inclination head up up to +80° on the Tilt Test.\n\nThe study aims to compare the contribution of intra-cardiac hydrostatic force to cardiac filling and ejection mechanics in a population of healthy volunteers and subjects with diabetes.\n\nThe goal is to define and compare the pre-load dependence of the cardiac function indices studied according to the anatomical supine posture with zero intra-cardiac hydrostatic gradient with the standing posture during which the hydrostatic force is expressed between the cardiac base and apex. The hypothesis is that cardiac filling and ejection are improved when the longitudinal axis of the heart is anatomically oriented in the standing position compared with the supine position, by restoring the intraventricular hydrostatic pressure gradient. Comparing a group of healthy subjects with a group of subjects with diabetes will enable to assess whether the dependence of cardiac function on the orientation of the heart in space is more marked in the presence of subclinical impairment of myocardial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affiliated to the social security system\n* Patient informed of the study and having signed an informed consent form\n* Type 1 diabetes for at least 10 years followed at Caen University Hospital, equipped with a continous glucose monitoring system\n\nExclusion Criteria:\n\n* Trained athletes (≥ 6 hours of sustained physical exercise \\>70% VO2max per week for \\> 6 months)\n* Chronic cardiovascular disease or cardiovascular treatment\n* Personal history of chemotherapy and/or thoracic radiotherapy\n* Cerebral and/or spinal disease\n* Inclusion of the subject in another biomedical research protocol of interventional type (during the study or in the 3 months prior to inclusion)\n* Pregnant, breast-feeding or parturient women\n* Adults under legal protection (guardianship, curators) or unable to express their consent or deprived of their freedom'}, 'identificationModule': {'nctId': 'NCT06190756', 'acronym': 'ACUITY', 'briefTitle': 'Impact of Gravity on Cardiac Hemodynamics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Effect of Intra-cardiac Hydrostatic Pressure Gradient in Cardiac Filling and Ejection', 'orgStudyIdInfo': {'id': '23-0077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T1 Diabetic group', 'description': 'Group with diabetic patients', 'interventionNames': ['Other: Cardiovascular and Baroreflex stimulation by Tilting', 'Other: Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure']}, {'type': 'OTHER', 'label': 'Healthy Control Group', 'description': 'Control group with healthy participants', 'interventionNames': ['Other: Cardiovascular and Baroreflex stimulation by Tilting', 'Other: Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure']}], 'interventions': [{'name': 'Cardiovascular and Baroreflex stimulation by Tilting', 'type': 'OTHER', 'otherNames': ['Tilt'], 'description': 'Tilt of the patient at 4 angles (22°, 42°, 58° and 80°), the order is randomized for 3 angles (22°, 42°, 58°) while 80° will always be last.', 'armGroupLabels': ['Healthy Control Group', 'T1 Diabetic group']}, {'name': 'Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure', 'type': 'OTHER', 'otherNames': ['LBNP'], 'description': 'The patient will undergo 4 level of LBNP (10Torr, 20Torr, 35Torr, 50Torr), the order is randomized for 3 intensities (10Torr, 20Torr, 35Torr) while 50Torr will always be last.', 'armGroupLabels': ['Healthy Control Group', 'T1 Diabetic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amir HODZIC, MD PhD', 'role': 'CONTACT', 'email': 'hodzic-a@chu-caen.fr', 'phone': '0231065503'}, {'name': 'Hervé NORMAND, MD PhD', 'role': 'CONTACT', 'email': 'herve.normand@unicaen.fr'}], 'facility': 'Inserm 1075 Comete, Unicaen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Amir HODZIC, MD PhD', 'role': 'CONTACT', 'email': 'hodzic-a@chu-caen.fr', 'phone': '0231065503'}, {'name': 'Hervé NORMAND, MD PhD', 'role': 'CONTACT', 'email': 'herve.normand@unicaen.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': 'INSERM UMR-S 1075 COMETE, Caen, France', 'class': 'UNKNOWN'}, {'name': 'CNRS UMR 5220 INSERM U1294 CREATIS ,Université Lyon 1, INSA Lyon, France', 'class': 'UNKNOWN'}, {'name': 'Jozef Stefan Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}