NIHP2019
Research type
Research Study
Full title
Non-ischemic preservation of the donor heart in heart transplantation - a randomized, controlled, multicenter trial
IRAS ID
267036
Contact name
Aaron Ranasinghe
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
Before heart transplant, the donor heart must be protected. Traditionally, this is achieved by stopping the heart and placing the heart in a cold solution whilst it is being transported to the recipient. This is to protect the heart by reducing how much energy it uses. This technique has been used since heart transplantation first started. We aim to investigate a new method of protecting the heart by connecting the cooled resting heart to a pump that provides the heart with a preservation solution that delivers oxygen and nutrients during transportation. We believe that this is better adapted to meeting the heart’s nutritional needs. Animal experiments have shown that hearts stored in such a box do better than ones stored using the old technique.
A safety study with 12 patients has not demonstrated any adverse effects. The aim of this study is to see whether transplant outcomes are better with the new method.
Patients meeting the inclusion criteria and listed for heart transplant by their clinical team will be approached. Only patients listed for heart transplant at an NHS commissioned Heart Transplant Centre will be recruited.
Patients will be randomised to either standard care or the new technique. All patients are on a national waiting list and are only randomised once a heart has been provisionally accepted for them by their clinical team.
Donor assessment is standardised in the UK and there are no changes to patient management before, during or after the heart transplant.
Patients will be followed up as part of the study for one year. There are no additional visits/investigations. The only additional tests are additional blood collection at the time when routine samples are obtained.
In total, 202 patients are expected to participate in seven different countries with 20-30 patients in each hospital.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0171
Date of REC Opinion
7 Jul 2020
REC opinion
Further Information Favourable Opinion