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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Heart transplantation 1
Procedure/SurgeryHeart 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/SurgeryHeart 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
Trial outcomes
Primary outcomes
Dead
Death, retransplantation or need of a mechanical heart pump.
Secondary outcomes
Frequency
Frequency of left-sided moderate or severe primary graft dysfunction
Sponsors and contacts
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