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Active, not recruiting Observational

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

NCT07125703 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-06-18
Last updated
2025-08-15

Condition(s) studied

Heart Transplant

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: \- Informed Consent available Exclusion Criteria: * Uncomplete donor data collection * Patients undergoing heart-lung bloc transplantation.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo Pavia Pavia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07125703 on ClinicalTrials.gov ↗ ← All trials in Italy