Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 4:11 PM
Study NCT ID:
NCT05768594
Status:
UNKNOWN
Last Update Posted:
2023-03-20
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omics in Valvular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Sample and Cardiology visit'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '24 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the two serum biomarkers of mitochondrial dysfunction', 'timeFrame': '1 year', 'description': 'Description of the two serum biomarkers of mitochondrial dysfunction Myeloperoxidase (MPO) and Lactoferrin (LF) and the indices of myocardial performance, systolic and diastolic function of the left ventricle in patients undergoing invasive (SAVR) or non-invasive (TAVR) monitoring.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction', 'timeFrame': '6 months', 'description': 'The two serum biomarkers and the myocardial performance indices, of the left ventricular systolic and diastolic function , evaluated in patients undergoing invasive (SAVR) or non-invasive monitoring (TAVR).'}, {'measure': 'Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance.', 'timeFrame': '6 months', 'description': 'The gene expression of the molecular pathways involved in ventricular remodeling and the correlation with echocardiographic parameters of left ventricular performance, will be evaluated through methods:\n\n* peripheral blood sampling\n* immunochemical analysis\n* evaluation of the oxidant and anti-oxidant capacity in vitro'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter Aortic Valve Replacement', 'Surgical Aortic Valve Replacement'], 'conditions': ['Stenosis, Aortic']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. For the achievement of these purposes, markers obtained from will be considered cardiovascular imaging methods, such as color Doppler echocardiography and isolated biomarkers from peripheral blood and heart tissue.', 'detailedDescription': 'Participation in this study includes, following enrollment, a visit of follow up (6/12 months) on the occasion of a concomitant medical check-up scheduled according to normal clinical practice. During these visits venous and contextual blood samples will be taken echocardiographic examination for re-evaluation of ejection fraction, as per normal practice clinic. The only variant will be the withdrawal of an additional aliquot of blood during the sampling standard blood.\n\nAll enrolled partecipants will undergo the optimal medical treatment provided by current and more recent guidelines for the treatment of heart valve disease. Joining this study will not result any modification of the current therapy, which will be established by the attending physician according to the correct one clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 patients admitted to our Department will be enrolled in our study of Cardiovascular Sciences with a diagnosis of severe aortic stenosis and preserved ejection fraction echocardiographic evaluation, divided into two categories:\n\n1. 15 patients undergoing surgical valve replacement (SAVR)\n2. 15 patients undergoing transcatheter aortic valve replacement (TAVR)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-30 patients with a diagnosis of severe aortic stenosis and preserved ejection fraction to echocardiographic evaluation\n\nExclusion Criteria:\n\n* inflammatory;\n* infectious diseases;\n* neoplasms;\n* ailments immunological or haematological;\n* treatment with anti-inflammatory drugs except aspirin a low dose (75-160 mg);\n* age \\> 85 years;\n* advanced chronic kidney disease with filtrate glomerular heart rate (eGFR) estimated by MDRD equation \\<30 ml/min./1.73 m2.'}, 'identificationModule': {'nctId': 'NCT05768594', 'acronym': 'OVERLOAD', 'briefTitle': 'Omics in Valvular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Omics in Valvular Disease: Biomarkers of Cardiac Remodeling, Left Ventricular Function, Intensive Care Unit Outcome, and Doppler Echocardiography (OVERLOAD)', 'orgStudyIdInfo': {'id': '2821'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with aortic stenosis, surgical valve replacement', 'description': '15 patients undergoing surgical valve replacement (SAVR)', 'interventionNames': ['Other: Blood sample']}, {'label': 'Patients with aortic stenosis, undergoing transcatheter aortic valve implantation', 'description': '15 patients undergoing transcatheter aortic valve replacement (TAVR)', 'interventionNames': ['Other: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'otherNames': ['Color Doppler echocardiogram'], 'description': 'After blood sampling, patients will undergo a Color Doppler Echocardiogram, a non-invasive method', 'armGroupLabels': ['Patients with aortic stenosis, surgical valve replacement', 'Patients with aortic stenosis, undergoing transcatheter aortic valve implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanna GL Liuzzo', 'role': 'CONTACT', 'email': 'giovanna.liuzzo@policlinicogemelli.it', 'phone': '+39 06/30154187'}], 'facility': 'Fondazione Policlinico Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Liuzzo LG Giovanna', 'role': 'CONTACT', 'email': 'giovanna.liuzzo@policlinicogemelli.it', 'phone': '+39 06/30154187'}, {'name': 'Daniela DP Pedicino', 'role': 'CONTACT', 'email': 'daniela.pedicino@policlinicogemelli.it', 'phone': '+39 06/30154187'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Liuzzo Giovanna', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}