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RECRUITING
NCT04393181

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

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2022-04-05

Completion Date

2027-04-01

Last Updated

2022-05-02

Healthy Volunteers

No

Interventions

PROCEDURE

Heart 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.

PROCEDURE

Heart 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).

Locations (1)

Sahlgrenska University Hostpial

Gothenburg, Västra Götaland County, Sweden