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

NCT04393181 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-05-02

No results posted yet for this study

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.

Conditions

  • Heart Transplantation

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).

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Göran Dellgren, MD, PhD · Vastragotalandsregionen, Sahlgrenska University Hospital,Gothenburg, Sweden

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2027-04-01
Completion
2027-04-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04393181 on ClinicalTrials.gov