| Registry | NCT07125703, acronym MetabolHeart |
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| Status | Active not recruiting |
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| Study type | Observational |
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| Enrollment | 14 (Actual) |
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| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia (Other) |
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| Conditions | Heart Transplant |
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| Dates | start 2024-06-18, primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2025-08-15, last updated 2025-08-15 |
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| Locations | 1 site in Italy |
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All trials for Heart Transplant
-Summary
This is a single center retrospective/prospective observational study with additional procedures meant to evaluate molecular mechanisms underlying injury in donor's heart.
The 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.
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+Outcome measures
Primary outcomes
- 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 [Within 24 hours post transplantation]
Secondary outcomes
- 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) [At 1, 6, 12 months after transplant]
- Left ventricular failure (LV EF <40%) within 24 hours post transplantation [Within 24 hours post transplantation]
- Right ventricular failure (TAPSE <16% and/or FAC < 35% and/or S' wave velocity < 10 cm/sec) within 24 hours post transplantation [Within 24 hours post transplantation]
- 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) [At 1, 6, 12 months after transplant]
- Death for graft failure within 24 hours post transplantation [Within 24 hours post transplantation]
- ECMO within 24 hours of transplant for ventricular failure [Within 24 hours of transplant]
- IABP within 24 hours of transplant for ventricular failure [Within 24 hours of transplant]
- Echocardiographic parameters: E/A>>1; DT<150 msec; E/e'>15, atrial strain at 1, 6, 12 months after transplant (in absence of rejection) [At 1, 6, 12 months after transplant]
- Death at 1, 6, 12 months after transplant (in absence of rejection [At 1, 6, 12 months after transplant]
- Trend of cardiac biomarker (BNP), trend of TNIhs, angiotensinogen, ADIPOQ, HGFAC, IGFBP3, other markers of ischaemia [At first and third week]
+Eligibility
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria:
\- Informed Consent available
Exclusion Criteria:
* Uncomplete donor data collection
* Patients undergoing heart-lung bloc transplantation.
+Locations (1)
| Facility | City | Country | Status |
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| Fondazione IRCCS Policlinico San Matteo | Pavia, Pavia | Italy | |