Clinical trial NCT01780597: Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Heart transplantation
Ev Vivo Perfusion
Cardiac function
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 hours
Secondary outcomes:
measure: 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?
timeFrame: 24 hours
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: Tyne & Wear
Study officials:
affiliation: Newcastle-upon-Tyne Hospitals NHS Trust
name: David Talbot, MBBS PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botha P, MacGowan GA, Dark JH. Sildenafil citrate augments myocardial protection in heart transplantation. Transplantation. 2010 Jan 27;89(2):169-77. doi: 10.1097/TP.0b013e3181c42b22.
citation: Dark JH. Lung transplantation from the non-heart beating donor. Transplantation. 2008 Jul 27;86(2):200-1. doi: 10.1097/TP.0b013e31817c87b6.
citation: Macgowan GA, Parry G, Schueler S, Hasan A. The decline in heart transplantation in the UK. BMJ. 2011 May 5;342:d2483. doi: 10.1136/bmj.d2483. No abstract available.
citation: Redfield MM. Heart failure--an epidemic of uncertain proportions. N Engl J Med. 2002 Oct 31;347(18):1442-4. doi: 10.1056/NEJMe020115. No abstract available.