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

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01780597
• Other study ID #: NewcastleNHS
• Status: Recruiting
• Start date: February 2013
• Est. completion date: April 2020

Study information

• Verified date: October 2018
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: David Talbot, MBBS PhD MD
• Phone: 01912336161
• Email: david.talbot[@]nuth.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United Kingdom	Freeman Hospital	Newcastle Upon Tyne	Tyne & Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

Dark JH. Lung transplantation from the non-heart beating donor. Transplantation. 2008 Jul 27;86(2):200-1. doi: 10.1097/TP.0b013e31817c87b6. Review. — View 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. — View Citation

Redfield MM. Heart failure--an epidemic of uncertain proportions. N Engl J Med. 2002 Oct 31;347(18):1442-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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