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NCT Number: NCT07125703

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed Consent available

Exclusion criteria

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

Treatment and study plan

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

    Time frame: Within 24 hours post transplantation

Secondary outcomes

  1. 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)

    Time frame: At 1, 6, 12 months after transplant

  2. Left ventricular failure (LV EF <40%) within 24 hours post transplantation

    Time frame: Within 24 hours post transplantation

  3. Right ventricular failure (TAPSE <16% and/or FAC < 35% and/or S' wave velocity < 10 cm/sec) within 24 hours post transplantation

    Time frame: Within 24 hours post transplantation

  4. 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)

    Time frame: At 1, 6, 12 months after transplant

  5. Death for graft failure within 24 hours post transplantation

    Time frame: Within 24 hours post transplantation

  6. ECMO within 24 hours of transplant for ventricular failure

    Time frame: Within 24 hours of transplant

  7. IABP within 24 hours of transplant for ventricular failure

    Time frame: Within 24 hours of transplant

  8. Echocardiographic parameters: E/A>>1; DT<150 msec; E/e'>15, atrial strain at 1, 6, 12 months after transplant (in absence of rejection)

    Time frame: At 1, 6, 12 months after transplant

  9. Death at 1, 6, 12 months after transplant (in absence of rejection

    Time frame: At 1, 6, 12 months after transplant

  10. Trend of cardiac biomarker (BNP), trend of TNIhs, angiotensinogen, ADIPOQ, HGFAC, IGFBP3, other markers of ischaemia

    Time frame: At first and third week

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: MetabolHeart

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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