Active not recruitingNAINTERVENTIONAL

Non-ischemic Preservation of the Donor Heart in Heart Transplantation

This research is looking into a new way to keep donor hearts healthy before a heart transplant. Currently, hearts are kept in cold storage. This study compares that standard method with a new technique that gently preserves the heart’s activity. The main goal is to find out if this newer method, called non-ischemic heart preservation, is safer and better than the usual way, leading to improved heart function both soon after the operation and in the long term for people who receive a new heart. They will track things like how well the new heart works, any complications, and how patients recover.

At a glance

Status

Active not recruiting

Phase

Sponsor

XVIVO Perfusion

Enrolment target

230

Start

25 Nov 2020

Estimated completion

31 Dec 2028

Heart Transplantation

What is this study about?

When someone needs a new heart, a donor heart is carefully removed and kept healthy until it can be transplanted. The usual way to do this is by putting the heart into very cold storage. This study is testing out a new, gentler method that keeps the heart more active during this time, rather than just cold and still. The aim is to see if this new method helps the donor heart stay healthier, making it work better once it’s in the patient’s body.

This important study wants to find out if using this newer preservation method leads to better results for patients who receive a heart transplant. Researchers will be looking at how well the new heart works right after the surgery and over the next year. They'll be checking for things like whether the new heart starts working well immediately, if there are any signs of the body rejecting the heart, or if the patient needs extra support for their circulation.

Ultimately, the hope is that this new preservation technique will mean donor hearts are in better condition for transplant. This could lead to fewer problems for patients, a quicker recovery, and a better chance of the new heart lasting longer. It’s about trying to give every heart transplant patient the best possible start with their new heart.

Key takeaways

Compares standard cold heart storage to a new, gentler preservation method.
Aims to improve how donor hearts function after transplant.
Looks at patient recovery and heart health up to a year after surgery.
Focuses on adult heart transplant patients and donors.
Participation involves routine follow-ups, with added research analysis on samples.

Who may be eligible?

This study is for adult patients who are on the waiting list for a heart transplant. You must be at least 18 years old to be considered for this research. The donor heart must also come from someone aged between 18 and 70 years old, who has been accepted as a suitable donor.

There are certain reasons why a patient might not be able to join the study. For example, if you've already had a solid organ transplant, or if you have certain serious kidney or liver problems. People with specific conditions like lupus, sarcoidosis, or amyloidosis, or those with an ongoing serious infection, also wouldn't be able to take part. If you're having other special treatments before your transplant, like certain types of blood filtering, you might also be excluded.

Similarly, certain donor hearts might not be suitable for the study. For instance, hearts from donors who have had previous open-heart surgery for a sternotomy (a cut down the breastbone) cannot be used in this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently on the waiting list for a heart transplant?
Do you have certain serious kidney or liver problems?
Have you had a previous solid organ transplant?
Do you have a current serious infection (septicemia)?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would be randomly chosen to receive a heart preserved either by the standard cold storage method or by the newer method. You wouldn't know which method was used, though the medical team handling the heart would. The study will involve regular check-ups and tests after your transplant, including blood tests and possibly heart biopsies, to see how well your new heart is working. These follow-ups will continue for various periods, with some important checks at 30 days and then up to 12 months after your transplant, to monitor both immediate and longer-term recovery and heart function.

Potential risks and benefits

Participating in this study might mean you receive a heart preserved with a new technique, which could potentially lead to better heart function and outcomes compared to the standard method. However, because this is a new method under investigation, there's always a small chance that it might not be better, or could even have unforeseen risks, though it's designed to be safe. Some samples taken during your usual care, like heart biopsies, will be looked at by researchers. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Allgemeines Krankenhaus der Stadt Wien
Verified postcode
Vienna, Austria
UZ Leuven
Verified postcode
Leuven, Belgium
Institut de cardiologie, Chirurgie thoracique et cardiovasculaire La Pitié Salpetrière
Verified postcode
Paris, France
Hôpital Bichat Claude-Bernard
Verified postcode
Paris, France
Klinikum der Universität München
Verified postcode
München, Germany
Deutschen Herzzentrum Berlin
Unverified
Berlin, Germany
Universitätsklinik der Ruhr-Universität Bochum
Verified postcode
Bad Oeynhausen, Germany
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany
Hannover Medical School
Verified postcode
Hanover, Germany
Azienda osedalaria di Padova
Verified postcode
Padova, Italy
Hospital Puerto de Hierro
Verified postcode
Madrid, Spain
Sahlgrenska University Hospital
Verified postcode
Gothenburg, Sweden

Common questions

What is the main purpose of this study?

To see if a new way of preserving donor hearts before a transplant is safer and more effective than the current standard method.

Will I know if my donor heart was preserved using the new method?

No, you and the doctors looking after you won't know which method was used to preserve the donor heart until after the study is over.

How long will I be followed in the study?

You will be followed up for important checks at 30 days and then up to 12 months after your heart transplant.

Are there any extra tests if I join the study?

Some samples, like heart biopsies, taken as part of your normal care will also be analysed for the study, but no extra invasive procedures are required just for this research.

What if I change my mind about participating?

You can withdraw from the study at any time, and this will not affect your medical care.