An observational study in Heart Failure, sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-11-01.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 17 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Organ Donors (declared brainstem dead). The hearts are only to be studied after death and removal from the body. Consent given first from the next of kin.
Exclusion Criteria:
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.
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.
Time frame: 12 hours
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.
Time frame: 24 hours
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Newcastle-upon-Tyne Hospitals NHS Trust