Impact of Donor Heart Function on Recipient Outcomes
IMPact of Donor Heart Function on Recipient Outcomes - a prospectiVE Study to Increase the Utilization of Donor HEARTs
This study looks at how the condition of donor hearts affects the recovery and health of people receiving heart transplants to see if using slightly damaged hearts can help more patients in need.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg, Västra Götaland County) |
| Trial ID | NCT04393181 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of donor heart function on the outcomes of heart transplant recipients. It aims to determine whether donor hearts with functional impairments, which are often reversible, can be safely utilized for transplantation. By systematically assessing donor heart function, the study seeks to identify which hearts are suitable for transplant, potentially increasing the number of available donor organs for patients with severe heart failure. The study will include patients who have been accepted for heart transplantation at the participating center and will gather data on their outcomes post-transplant.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 years or older who have been accepted for heart transplantation.
Not a fit: Patients with mental incapacity, language barriers, or those participating in conflicting studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the number of donor hearts available for transplantation, improving outcomes for patients with severe heart failure.
How similar studies have performed: While retrospective studies suggest that donor hearts with dysfunction can yield comparable outcomes to those with perfect function, this prospective approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * • 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.
Where this trial is running
Gothenburg, Västra Götaland County
- Sahlgrenska University Hostpial — Gothenburg, Västra Götaland County, Sweden (Recruiting)
Study contacts
- Principal investigator: Göran Dellgren, MD, PhD — Vastragotalandsregionen, Sahlgrenska University Hospital,Gothenburg, Sweden
- Study coordinator: Jonatan Oras, MD, PhD
- Email: jonatan.oras@vgregion.se
- Phone: +46736370350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.