Donor Heart Transplantation for Solid Organ Transplant

Overseen By Tae Kim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Prior cardiac transplant, Multi-organ transplant, Other trial, Unsafe condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-transplant period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods for performing heart transplants using hearts from donors who have experienced circulatory death (DCD), comparing them to the traditional method using donors who are brain dead (DBD). The study aims to determine if the outcomes are similar and if using DCD hearts can increase the number of available hearts for transplant. Eligible participants are individuals listed for a first-time heart transplant who can understand and consent to the trial's goals and risks. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could expand heart transplant options for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that DCD donor heart transplantation is safe?

Research has shown that using hearts from donors after circulatory death (DCD) is generally safe for heart transplants. One study found that the risk of serious heart problems within 30 days after a DCD transplant did not exceed that of transplants using hearts from donors after brain death (DBD). Another study demonstrated that short-term survival rates for DCD heart transplants are similar to those for DBD transplants, indicating comparable short-term outcomes for patients.

Overall, DCD heart transplants are considered safe and increase the number of available donor hearts. Participating in a trial involving DCD heart transplants does not appear to carry additional risk of major complications compared to traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of DCD Donor Heart Transplantation because it introduces innovative techniques for utilizing hearts from donors after circulatory death (DCD). Unlike the standard heart transplant process, which typically uses hearts from donors after brain death (DBD), this trial explores two unique strategies: Normothermic Regional Perfusion (NRP) and Direct Procurement and Perfusion (DPP) with the Organ Care System (OCS). NRP allows for the heart to be revived and assessed in a controlled setting, potentially improving the quality and viability of DCD hearts. DPP with OCS offers a portable system that maintains the heart in a near-physiological state, potentially increasing the donor pool and improving outcomes for patients in need of heart transplants.

What evidence suggests that this trial's treatments could be effective for heart transplantation?

This trial will compare DCD Donor Heart Transplantation with DBD Donor Heart Transplantation. Research has shown that hearts from DCD donors (those who donate after their heart stops) can function as well as hearts from DBD donors (those who donate after brain death) in transplants. One study found that 92.5% of people who received a DCD heart were alive after one year, compared to 90.3% of those who received a DBD heart. Another study found similar rejection rates: 15% for DCD and 19% for DBD. These findings suggest that DCD heart transplants are safe and effective, offering a viable option for patients needing a new heart. ^{1 6 7 8 9}

Who Is on the Research Team?

Fardad Esmailian, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need their first heart transplant and can understand the study's risks. They must sign consent forms to participate. People with a previous heart transplant, needing multiple organ transplants, or conditions that make the study unsafe are excluded.

Inclusion Criteria

Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research. Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion Criteria

You have had a heart transplant in the past.

You have had transplants involving multiple organs.

You have a medical condition that would make it unsafe for you to participate in the study or could affect the study's goals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a heart transplant from either DCD or DBD donors, with DCD hearts retrieved using NRP or DPP methods

Immediate post-transplant period

Follow-up

Participants are monitored for safety and effectiveness after heart transplantation, focusing on heart graft-related Serious Adverse Events

30 days

Extended Follow-up

Assessment of practical, financial, and logistical viability of using NRP vs. DPP for DCD donor hearts

1 year

What Are the Treatments Tested in This Trial?

Interventions

• DCD Donor Heart Transplantation

Trial Overview The trial compares two ways of getting donor hearts: one from donors after circulatory death (DCD) using special techniques (NRP or DPP), and another from donors after brain death (DBD) with standard methods. It checks if DCD hearts work as well as DBD ones.

How Is the Trial Designed?

Group I: DCD Donor Heart Transplantation Experimental Treatment 1 Intervention

If the heart offer is from a DCD donor, the heart will be retrieved using one of two strategies: Normothermic Regional Perfusion (NRP) or Direct Procurement and Perfusion (DPP). NRP procedures will be used to procure all DCD hearts unless contraindicated or prohibited by the donor hospital. In the event the donor hospital does not allow NRP for cardiac organ procurement, or the target number of eight DCD transplants with NRP has been achieved, DPP with the Organ Care System (OCS) should be utilized.

Group II: DBD Donor Heart Transplantation Experimental Treatment 1 Intervention

If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1. annalscts.com annalscts.com/article/view/17159/html

Donation after circulatory death transplantation: a ... Acute rejection was 15% and 19% in DCD and DBD patients respectively (OR, 1.0; 95% CI: 0.6–1.8; P=0.9). Thirty-day survival was similar between ...

2. annalsthoracicsurgeryshortrep.org annalsthoracicsurgeryshortrep.org/article/S2772-9931(24)00377-2/fulltext

Outcomes of Donation After Circulatory Death Heart ... Outcomes after DCD heart transplantation using TA-NRP remain encouraging with acceptable rates of rejection, PGD, CAV, and survival at 1 year.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2212438

Transplantation Outcomes with Donor Hearts after ... Data showing the efficacy and safety of the transplantation of hearts obtained from donors after circulatory death as compared with hearts obtained from donors ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37793748/

Outcomes of Heart Transplant Donation After Circulatory ... DCD donors were younger and had fewer comorbidities than DBD donors. DCD recipients were less often hospitalized before transplantation and less ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.122.009844

Early Outcomes of Heart Transplantation Using Donation ... DCD donors were more likely to be younger, male, and White. After propensity matching, 1-year survival was 92.5% for DCD versus 90.3% for ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.124.011678

Donation After Circulatory Death Heart Transplant: Current ... This review aims to present the current state and future trajectory of DCD-heart transplant, examine key differences between DCD and donation after brain death, ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2023.08.006

Outcomes of Heart Transplant Donation After Circulatory ... In the largest single-center comparison of DCD and DBD heart transplantations to date, outcomes among DCD recipients are noninferior to those of DBD recipients.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38578698/

Outcomes of Heart Transplantation From Donation After ... Donation after circulatory death (DCD) heart transplantation (HTx) significantly expands the donor pool and reduces waitlist mortality.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0022522322005335

Heart transplantation using donation after circulatory death ... Heart transplantation with donation after circulatory death donors has short-term survival comparable to donation after brain death transplants.