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

NCT07125703 | Active Not Recruiting

• 1 other identifier: MetabolHeart
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant

Outcome Measures

Primary Outcomes (1)

• 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 (10)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potentially all patients undergoing heart transplant at the Cardiac Surgery - Fondazione IRCCS Policlinico San Matteo, Pavia until 31-12-2024

You may qualify if:

• \- Informed Consent available

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stefano Pelenghi

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: June 18, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-02

Locations

IT (1)