Clinical trial Recruiting at 1 site Observational Ages 18 and up

Impact of Donor Heart Function on Recipient Outcomes

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

Run by Vastra Gotaland Region · NCT04393181 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorVastra Gotaland Region
Government
Locations1 site (Gothenburg, Västra Götaland County)
StatusRecruiting
StartedApril 5, 2022
Main results expectedApril 1, 2027
Study endsApril 1, 2027
Registry record updatedMay 2, 2022
Trial IDNCT04393181 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients aged 18 years or older who have been accepted for heart transplantation.

Probably not a fit

Patients with mental incapacity, language barriers, or those participating in conflicting studies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.