Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.
Recruitment status was Not yet recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||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.|
- 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. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]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.
- 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? [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Myocardial biopsies, serum samples.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Organ Donors (declared Brainstem-Dead)
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780597
|Contact: David Talbot, MBBS PhD MD||01912336161 ext firstname.lastname@example.org|
|Freeman Hospital||Not yet recruiting|
|Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN|
|Contact: David Talbot, MBBS PhD MD 01912336161 ext 39110 email@example.com|
|Sub-Investigator: Guy MacGowan, MBBS MD|
|Sub-Investigator: Omar Mownah, MBBS BSc|
|Principal Investigator:||David Talbot, MBBS PhD MD||Newcastle-upon-Tyne Hospitals NHS Trust|