RecruitingNCT04393181

IMPact of Donor Heart Function on Recipient Outcomes - a prospectiVE Study to Increase the Utilization of Donor HEARTs

Sponsor

Vastra Gotaland Region

Enrollment

500 participants

Start Date

Apr 5, 2022

Study Type

OBSERVATIONAL

Conditions

Heart Transplantation

Summary

Severe heart failure is a diagnosis with a very poor prognosis. Heart transplantation is the best treatment for terminal heart failure but this type of treatment is limited by the number of available organs. About 20-25% of possible donor hearts are not considered for transplantation because they have some form of functional impairment. The functional impairment affecting organ donors is, however, usually reversible. A number of retrospective studies show that cardiac function recovers and recipients of hearts with dysfunction do not have worse outcomes compared to recipients of hearts with perfect cardiac function. However, there are no prospective studies on whether the functional impairment of the donor heart is of significance for the recipient. With a systematic and simple investigation of the heart, it should be possible to identify the hearts that are safe to transplant. This will thus increase the number of available donors.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Patient who has been accepted for heart transplantation at the participating transplantation center
The research subject has given written consent to participate in the study
Aged 18 years or older

Exclusion Criteria2

Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Another study, where the patient is included, which is not considered compatible with the current study.

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Interventions

PROCEDUREHeart transplantation 1

Heart transplantation will be performed according to local routines. Recipients will be transplanted with a donor heart with left ventricular dysfunction, defined as an ejection fraction less than 50% or regional hypokinesia.

PROCEDUREHeart transplantation 2

Heart transplantation will be performed according to local routines. Recipients will be transplanted with a donor heart with normal function, according to the recommendations from The International Society for Heart and Lung Transplantation (ISHLT).