Non-ischemic Preservation of the Donor Heart in Heart Transplantation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    202
  • sponsor
    XVIVO Perfusion
Updated on 9 March 2021
coagulopathy
organ transplantation
heart transplant
heart disease
lupus
heart transplantation

Summary

The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.

Description

This study will investigate if non-ischemic heart preservation (NIHP) with the XVIVO heart preservation devices could improve clinical outcome of patients receiving hearts after use of the technology compared to after use of standard cold ischemic preservation. This will be investigated in a European multicentre randomized controlled clinical trial. For technical reasons, blinding to the involved clinical personnel is not possible, however, biopsies will be blinded to study pathologists. The trial will include 202 recipients that have been randomized through their heart donor. The primary outcome of the study is a clinically relevant composite including graft survival, primary graft dysfunction, rejection and use of circulatory mechanical support, within 30 days and also including Cardiac Allograft Vasculopathy within 12 months. As secondary outcomes, molecular markers related to cardiac injury CKMB, ProBNP and TNI will be investigated as well as markers of the inflammatory response. Safety aspects such as effect on other organs and machine defects will also be monitored. The study population is adults, listed for heart transplantation and donors accepted as heart donors according to standard hospital procedures. Specific recipient exclusion criteria related to pre-transplant ECMO support, patients undergoing pre-transplant desensitization protocol, patients with Grown-Up Congenital Heart Disease, patients with severe kidney or liver dysfunction, patients with septicaemia, and patients diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis are excluded. Cardiac death donors and donors with previous sternotomy are excluded. The study hypothesis is that NIHP better preserves the endothelium and myocyte function of the heart resulting in improved short- and medium-term recipient outcome, without inducing any new significant risks to the retrieved heart or the recipient. This is believed to be accomplished through continuous oxygenation of the heart via perfusion of the coronary arteries using an optimized preservation solution, mimicking the normal environment for the endothelium.

Details
Condition Heart Transplantation, heart surgery, Organ Transplantation, Organ Transplant - Pediatric, Cardiac Surgery, Organ Transplant, heart transplant, cardiac transplant, cardiac transplantation
Treatment XVIVO heart preservation devices, Standard ICSS
Clinical Study IdentifierNCT03991923
SponsorXVIVO Perfusion
Last Modified on9 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Signed informed consent form
Listed for heart transplantation
Inclusion criteria donor
Age 18 and 70 years
Accepted as heart donor by the transplant team
(research consent from the donor if required in country)

Exclusion Criteria

Previous solid organ transplantation
Grown-up congenital heart disease (GUCH)
Kidney failure eGFR<40 at listing, 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
Patient diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis
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
Combined organ transplantation candidates
Patient already consented for another transplant related intervention study
Patients under pre-transplant desensitization protocol
Short term mechanical circulatory support pre-transplantation (Except for Intra-Aortic Balloon Pump)
Exclusion criteria donor
Previous sternotomy
DCD hearts
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