NCT01780597

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 17 (estimated)
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Heart Failure

Timeline

• Start date: 2013-02-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2013-01-31
• Last updated: 2018-11-01

Locations

1 site across 1 country: United Kingdom