Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.

Study Overview
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Brief Summary
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The main question to be asked in this study is what is the potential for human hearts that have been deemed unacceptable for transplant, to be explanted and re-animated in a controlled, external environment to be assessed? Furthermore would the reanimated hearts be able to undergo improvement in their function in this external environment. Ultimately this may lead to an increase the number of hearts available for transplantation.

Detailed Description
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Year on year with improvement in road safety and improvement in neurosurgery the number of ideal young brain dead donors have been declining whilst the number of more marginal donors have been increasing. The consequence of this is the number of heart transplants being performed have steadily declined. At present there are 600 hearts from brain dead donors offered for transplant every year in the United Kingdom (UK). Of these 200 have anatomical reasons why they cannot be used for transplant such as ischaemic heart disease. 100 are transplanted and the remaining 300 hearts are judged to have inferior function which probably occurs as a direct result of brain death (Dark). Ex vivo 'rig' testing has been developed for lungs that were judged unsuitable for transplantation. As a result several donor lungs have been 'improved' by warm perfusion on the rig to the extent that they became suitable for transplantation and so national lung transplant rates are increasing (Dark). The aim would be to develop a similar approach for the heart.

Official Title
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Ex Vivo Assessment of Human Hearts Deemed Unsuitable for Cardiac Transplant With the Ultimate Aim of Increasing the Number of Hearts Available for Transplant for Cardiac Failure Patients.

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is brain dead and their relative is willing to give informed consent Male or Female, aged between 18 and 75 years Heart is not eligible for transplantation Exclusion Criteria: Participant's relative refuses consent Brain dead donor whose heart is eligible for transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Organ Donors (declared Brainstem-Dead)<br>This group of subjects is defined as those who have previously expressed their future wish to organ donation and who have suffered events leading to declaration of brainstem-death. Furthermore these subjects will have had their hearts declined for heart transplantation on the basis of poor function. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigators aim to measure an improvement in cardiac function (ie contractility) by measuring the Pressure Change/Time max (dP/dT), in mmHg/second, of the heart once it has achieved reanimation on the ex vivo circuit. | Can human hearts that have been deemed unacceptable for transplant be re-animated in a controlled, external environment to be assessed? Furthermore, can their function (contractility) be improved by ex vivo reperfusion? This will be measured using conductance catheters to measure the dP/dT max (mmHg/second) at various time intervals. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can their function (contractility measured in mmHg/second) of the hearts be improved by an additional re-oxygenation step during the cold phase of heart preservation? | Can these hearts be improved during the cold phase of transportation by either continuous circulation of preservation solution or oxygen gas through the heart? Hearts will be reperfused on the ex vivo circuit having been subjected to either method of preservation and their contractility measurements (mmHg/sec) once reanimated will be compared. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart transplantation, Ev Vivo Perfusion, Cardiac function