Precision Medicine in the Management of Heart Transplant Recipients

NCT06774794 | Recruiting

• 2 other identifiers: Precision-HTRC-2022-2773280
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to demonstrate that a multiparametric approach, based on the integration of biomolecular, histological, imaging, and clinical information, along with the use of machine learning methods, can identify among heart transplant patients those at higher risk of rejection, infectious events, and chronic graft dysfunction. Patients have been and will be treated according to clinical practice, in accordance with the physician's judgment and the information provided in the Technical Data Sheet of each individual product used in concomitant therapies, if administered according to clinical practice. The diagnostic-therapeutic pathway of the patients will not be in any way influenced by the results of tissue tests performed for the purposes of the study

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

• Histological diagnosis of rejection leading to a change in immunosuppressive therapy according to clinical practice.

  Histological diagnosis

  5 years

Secondary Outcomes (4)

• Symptomatic infection requiring treatment with antimicrobial drugs

  5 years

• Development of myocardial fibrosis diagnosed on cardiac MRI

  5 years

• Hospitalization for any cause.

  5 years

• Mortality from any cause.

  5 years

Eligibility Criteria

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

Study Population

All adult patients undergoing orthotopic heart transplantation, attending the SSD Heart Failure and Transplants unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna, will be enrolled from 01/02/2023 to 31/12/2027. Each patient will be followed according to standard clinical care practices; the minimum follow-up for each patient will be 6 months.

You may qualify if:

• Age ≥ 18 years
• Have received an orthotopic heart transplant
• Clinical indication for performing a myocardial biopsy (either as part of standard monitoring or for suspected rejection)
• Obtaining informed consent

You may not qualify if:

• Severe complications in the post-operative phase that may limit the patient's short-term survival.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Luciano

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood samples, from which cfDNA will be extracted.

Study Officials

• Luciano G Potena, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Potena, MD

CONTACT

0512143725; scompenso.trapiantocuore@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: September 4, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2025

Record last verified: 2024-12

Locations

IT (1)