Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-02 @ 1:18 PM
Study NCT ID:
NCT07125703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study With Additional Procedures: Metabolomic and Ultrastructural Findings of Allograft in Heart Transplantation and Their Correlation With Graft Dysfunction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Biventricular failure: left ventricular failure (LV EF <40%) and right ventricular failure (TAPSE <16% and/or FAC < 35% and/or S' wave velocity < 10 cm/sec) within 24 hours post transplantation", 'timeFrame': 'Within 24 hours post transplantation'}], 'secondaryOutcomes': [{'measure': 'Left ventricular dysfunction (longitudinal global strain (LGS) < -14% at 1 month and <-17% at 6 and 12 months and/or FEvsx <50%) at 1, 6, 12 months after transplant (in absence of rejection)', 'timeFrame': 'At 1, 6, 12 months after transplant'}, {'measure': 'Left ventricular failure (LV EF <40%) within 24 hours post transplantation', 'timeFrame': 'Within 24 hours post transplantation'}, {'measure': "Right ventricular failure (TAPSE <16% and/or FAC < 35% and/or S' wave velocity < 10 cm/sec) within 24 hours post transplantation", 'timeFrame': 'Within 24 hours post transplantation'}, {'measure': 'Hemodynamic: Cardiac Index < 2 L/min/mq, wedge pressure >20 mmHg, right atrial pressure (RAP > 15 mmHg) within 24 hours post transplantation and at 1, 6, 12 months after transplant (in absence of rejection)', 'timeFrame': 'At 1, 6, 12 months after transplant'}, {'measure': 'Death for graft failure within 24 hours post transplantation', 'timeFrame': 'Within 24 hours post transplantation'}, {'measure': 'ECMO within 24 hours of transplant for ventricular failure', 'timeFrame': 'Within 24 hours of transplant'}, {'measure': 'IABP within 24 hours of transplant for ventricular failure', 'timeFrame': 'Within 24 hours of transplant'}, {'measure': "Echocardiographic parameters: E/A>>1; DT<150 msec; E/e'>15, atrial strain at 1, 6, 12 months after transplant (in absence of rejection)", 'timeFrame': 'At 1, 6, 12 months after transplant'}, {'measure': 'Death at 1, 6, 12 months after transplant (in absence of rejection', 'timeFrame': 'At 1, 6, 12 months after transplant'}, {'measure': 'Trend of cardiac biomarker (BNP), trend of TNIhs, angiotensinogen, ADIPOQ, HGFAC, IGFBP3, other markers of ischaemia', 'timeFrame': 'At first and third week'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Transplant']}, 'descriptionModule': {'briefSummary': "This is a single center retrospective/prospective observational study with additional procedures meant to evaluate molecular mechanisms underlying injury in donor's heart.\n\nThe research project will focus on Metabolomics by NMR and LC-MS and ultrastructural analysis using electron microscopy of endomyocardial biopsies (EMB).In our clinical protocol of heart transplantation, myocardial biopsy samples are routinely provided at intraoperative and postoperative time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potentially all patients undergoing heart transplant at the Cardiac Surgery - Fondazione IRCCS Policlinico San Matteo, Pavia until 31-12-2024', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Informed Consent available\n\nExclusion Criteria:\n\n* Uncomplete donor data collection\n* Patients undergoing heart-lung bloc transplantation.'}, 'identificationModule': {'nctId': 'NCT07125703', 'acronym': 'MetabolHeart', 'briefTitle': 'Observational Study With Additional Procedures: Metabolomic and Ultrastructural Findings of Allograft in Heart Transplantation and Their Correlation With Graft Dysfunction.', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Observational Study With Additional Procedures: Metabolomic and Ultrastructural Findings of Allograft in Heart Transplantation and Their Correlation With Graft Dysfunction.', 'orgStudyIdInfo': {'id': 'MetabolHeart'}}, 'contactsLocationsModule': {'locations': [{'city': 'Pavia', 'state': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Stefano Pelenghi', 'investigatorFullName': 'Stefano Pelenghi', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}