NCT04066127Enrolling by invitation
Non-ischaemic Heart Preservation Versus Standard Cold Storage in Human Heart Transplantation
A Randomized Controlled Trial Comparing a New State-of-the-art Non Ischemic Heart Preservation Method With the Standard Ischemic Cold Static Storage Method of Donor Hearts in Adult Heart Transplantation
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The overall aim of this study is to compare a new state-of-the-art ex-vivo organ preservation method with standard ischemic cold static storage of donor hearts in adult cardiac transplantation. Standard heart preservation before transplantation consists of cold ischemic storage of the heart. Clinical studies have shown that the morbidity and mortality risk increases with the extension of the allograft ischemic time over four hours. For each additional hour the mortality risk increase with 25% the first year. This time constraint is costly and results in severe logistical problems, leading to loss of transplantable organs. The preliminary results from our safety study, where six patients transplanted with the new state-of-the-art ex-vivo organ preservation method, have shown promising results. The study is a multicenter, prospective, open, blinded endpoint, randomized, controlled clinical trial. The primary end-point is survival free of acute cellular rejection (ACR) and retransplantation within 1-year post-transplant. ACR will be assessed blinded. The secondary end-points are ischemia/reperfusion injury, early graft dysfunction, and QoL.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 21 Aug 2019
- Start date
- 1 Jul 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Region Skane
- NCT number
- NCT04066127
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 1 Jul 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous solid organ transplantation
- Patients under pre-transplant desensitization protocol
- Short term mechanical support pre-transplant (ECMO)
- Combined organ transplantation candidates
- Patient already consented for another transplant related intervention study
- Previous sternotomy
Other illness
- Grown-up congenital heart disease (GUCH)
- Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia
Lab values
- Kidney failure eGFR\<40, calculated by CDK-EPI Creatinine, or ultrafiltration or dialysis or rapidly deteriorating kidney function due to a diagnosed renal disease
Other
- 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
- Patient diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis
- DCD hearts
Who the study is looking for
- Age ≥18 years
- Signed informed consent form
- Listed for heart transplantation
- Age ≤70 years
- Accepted as heart donor by the transplant team (research consent from the donor if required in country)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.