Late exit WP4

HOPE

Optimizing HOPE Perfusion for Transplantation

This preclinical translational study aims to improve the preservation of donor hearts during hypothermic oxygenated machine perfusion (HOPE). Although this technology has already demonstrated the ability to substantially extend donor heart preservation, further optimization is needed to support wider clinical implementation and maximize donor heart utilization.

Study overview

The project focuses on three complementary objectives. First, we will identify biomarkers that provide real-time information on donor heart quality during preservation. Such biomarkers could support objective decision-making regarding organ suitability and improve the safe use of extended preservation times. Second, we will optimize the composition of the perfusion solution to further enhance preservation efficacy while simplifying the preservation protocol. Finally, we will evaluate the potential economic impact of prolonged machine perfusion to better understand its value for clinical implementation and healthcare systems.

Together, these studies will generate new insights into the biological processes that occur during prolonged heart preservation and contribute to the development of more effective, evidence-based preservation strategies for clinical heart transplantation.


Objectives

  1. Identify and validate biomarkers (including point-of-care tests) to accurately assess donor heart viability during hypothermic oxygenated perfusion (HOPE).
  2. Optimize perfusion protocols based on systematic experimental findings.
  3. Conduct assessments of the economic feasibility and potential impact on transplant outcomes and donor organ utilization.

Study design

This is a preclinical study using porcine donor hearts preserved with clinically relevant hypothermic oxygenated machine perfusion technology. Hearts will be preserved for varying durations to investigate biological changes occurring during both standard and extended preservation.

During preservation, perfusate samples will be collected at regular intervals to evaluate biomarkers associated with graft quality and preservation success. Following preservation, cardiac function will be assessed after controlled rewarming using an experimental working-heart system. Biomarker profiles will subsequently be related to functional recovery to identify markers that best predict successful preservation.

In parallel, different perfusion strategies will be evaluated to determine whether modifications of the perfusion solution can further improve preservation outcomes while maintaining optimal cardiac function after prolonged storage.

In addition, a health economic analysis will be performed to assess the potential cost-effectiveness of prolonged hypothermic machine perfusion compared with current preservation strategies. This analysis will explore the expected impact on donor heart utilization, transplantation logistics, healthcare costs, and patient outcomes, providing important information to support future clinical adoption.

The knowledge generated in this project will support the translation of extended hypothermic machine perfusion into routine clinical practice and contribute to increasing the availability and quality of donor hearts for transplantation.

Participating sites

  • UMC Utrecht — Netherlands

Consortium partners

Organisations contributing sites, technology, or expertise to this clinical study.

Universitair Medisch Centrum Utrecht (Umc Utrecht)

Country
Netherlands
Role
Consortium partner
Lead partner

Xvivo Perfusion AB

Country
Sweden
Role
Consortium partner