IMPact of Donor Heart Function on Recipient Outcomes - a prospectiVE Study to Increase the Utilization of Donor HEARTs
1 other identifier
observational
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedStudy Start
First participant enrolled
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
May 2, 2022
April 1, 2022
5 years
May 13, 2020
April 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Dead
Death, retransplantation or need of a mechanical heart pump.
One year after heart transplantation.
Secondary Outcomes (1)
Frequency
24 hour after transplantation
Study Arms (2)
recipients of hearts with impaired function
Patient who has been accepted for heart transplantation at the participating transplantation center and who will receive heart with impaired function
recipients of hearts with normal function
Patient who has been accepted for heart transplantation at the participating transplantation center and who will receive heart with normal function
Interventions
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 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).
Eligibility Criteria
Subjects with severe heart failure accepted for heart transplantation at Transplantationscentrum, Sahlgrenska University Hospital, Gothenburg, Sweden
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska University Hostpial
Gothenburg, Västra Götaland County, Sweden
Biospecimen
The hearts of organ donors that are not transplanted will be used for tissue analysis when logistically feasible and permission is granted, in accordance with current regulations. The hearts will be examined for coronary heart disease and heart attack. Tissue samples will be taken from several areas with affected (in such donors) or normal function. Blood samples from donors will be taken when logistically feasible and permission is granted, in accordance with current regulations. From the donors, 20 ml blood is planned to be taken on up to three occasions, i.e. a total of 60 ml blood. Blood samples for analysis of troponin T and NTproBNP will be taken as part of normal healthcare routines and destroyed immediately after analysis .
Study Officials
- PRINCIPAL INVESTIGATOR
Göran Dellgren, MD, PhD
Vastragotalandsregionen, Sahlgrenska University Hospital,Gothenburg, Sweden
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 19, 2020
Study Start
April 5, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
May 2, 2022
Record last verified: 2022-04