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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• 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.

Trial population

Subjects with severe heart failure accepted for heart transplantation at Transplantationscentrum, Sahlgrenska University Hospital, Gothenburg, Sweden

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Heart transplantation 1

    Procedure/Surgery

    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.

  • Heart transplantation 2

    Procedure/Surgery

    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).

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: recipients of hearts with impaired function1 intervention
Group B: recipients of hearts with normal function1 intervention

Trial outcomes

Primary outcomes

1

Dead

Death, retransplantation or need of a mechanical heart pump.

Time frame
One year after heart transplantation.

Secondary outcomes

1

Frequency

Frequency of left-sided moderate or severe primary graft dysfunction

Time frame
24 hour after transplantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.