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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Professor David Talbot, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01780597
First received: January 25, 2013
Last updated: February 3, 2013
Last verified: February 2013
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 17
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)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780597

Contacts
Contact: David Talbot, MBBS PhD MD 01912336161 ext 39110 david.talbot@nuth.nhs.uk

Locations
United Kingdom
Freeman Hospital Not yet recruiting
Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN
Contact: David Talbot, MBBS PhD MD    01912336161 ext 39110    david.talbot@nuth.nhs.uk   
Sub-Investigator: Guy MacGowan, MBBS MD         
Sub-Investigator: Omar Mownah, MBBS BSc         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Principal Investigator: David Talbot, MBBS PhD MD Newcastle-upon-Tyne Hospitals NHS Trust
  More Information

Publications:
Responsible Party: Professor David Talbot, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01780597     History of Changes
Other Study ID Numbers: NewcastleNHS
Study First Received: January 25, 2013
Last Updated: February 3, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Heart transplantation
Ev Vivo Perfusion
Cardiac function

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014