Non-ischaemic Heart Preservation Versus Standard Cold Storage in Human Heart Transplantation

Launched by REGION SKANE · Aug 21, 2019

Keywords

ClinConnect Summary

This trial is testing a new way to preserve donor hearts before transplant. Researchers are comparing Non-ischemic Heart Preservation (NIHP)—which uses a portable machine to keep the donor heart alive and supplied with fluid at a cold temperature—with the standard approach of keeping the heart just on ice (standard cold storage, SCS). The goal is to see if NIHP helps patients survive for at least a year after transplant without acute rejection and the need for another transplant, while also looking at heart function, quality of life, and safety.

People who may be eligible are adults 18 and older who are listed for a heart transplant. Donor hearts must be 70 years old or younger. Exclusions include a history of prior organ transplant, certain kidney problems, some liver or immune issues, ongoing severe infection, blood group incompatibilities, or other specific health or transplant reasons. If enrolled, you’d be randomly assigned to receive a heart preserved with NIHP or with SCS. You’ll have regular follow-up for about a year after transplant, including heart tests, a rejection check done by a blinded reviewer, quality-of-life questionnaires, and safety monitoring for possible complications. The study began in 2020 at several Swedish centers and aims to enroll about 66 participants, with completion expected around 2026.

Gender

ALL

Eligibility criteria

• Inclusion Criteria recipient:
• • Age ≥18 years
• • Signed informed consent form
• • Listed for heart transplantation
• Exclusion Criteria recipient:
• • Previous solid organ transplantation
• • Grown-up congenital heart disease (GUCH)
• • Kidney failure eGFR\<40, calculated by CDK-EPI Creatinine, or ultrafiltration or dialysis or rapidly deteriorating kidney function due to a diagnosed renal disease
• • Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia
• • Ongoing septicemia defined as positive blood culture (including with a durable VAD)
• • Incompatible blood group
• • Not able to understand the information provided during the informed consent procedure
• • Patients under pre-transplant desensitization protocol
• • Short term mechanical support pre-transplant (ECMO)
• • Patient diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis
• • Combined organ transplantation candidates
• • Patient already consented for another transplant related intervention study
• Inclusion criteria donor:
• • Age ≤70 years
• • Accepted as heart donor by the transplant team (research consent from the donor if required in country)
• Exclusion criteria donor:
• • Previous sternotomy
• • DCD hearts