Clinical Trial

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

Recruiting
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-05-18; most recent amendment 2022-04-29.
Status change: Not Yet Recruiting → Recruiting 2022-04-29
Trial Details
NCT Number NCT04393181
Lead Sponsor Vastra Gotaland Region
Conditions Heart Transplantation
Enrollment 500 participants
Start Date 2022-04-05
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2022-05-02