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

NCT ID: NCT07125703

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-18

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\- Informed Consent available

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Stefano Pelenghi

Stefano Pelenghi

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy

Site Status

Countries

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Italy

Other Identifiers

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MetabolHeart

Identifier Type: -

Identifier Source: org_study_id

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