Observational Study With Additional Procedures: Metabolomic and Ultrastructural Findings of Allograft in Heart Transplantation and Their Correlation With Graft Dysfunction.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07125703

Acronym

MetabolHeart

Enrollment

Registered

2025-08-15

Start date

2024-06-18

Completion date

2025-12-31

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

\- Informed Consent available

Exclusion criteria

* Uncomplete donor data collection * Patients undergoing heart-lung bloc transplantation.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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
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
ECMO within 24 hours of transplant for ventricular failure	Within 24 hours of transplant

Countries

Italy

Outcome results