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Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-transplant period

30 Participants Needed

Donor Heart Transplantation for Solid Organ Transplant

Overseen ByTae 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment DCD Donor Heart Transplantation?

DCD heart transplantation is becoming more common and helps increase the number of available donor hearts, which can reduce wait times for patients needing a transplant. While early survival rates are promising, more data is needed to fully understand the long-term outcomes and potential for rejection.¹ ² ³ ⁴ ⁵

Is DCD donor heart transplantation generally safe for humans?

DCD donor heart transplantation is becoming more common and is considered an evolving practice, but there is limited data on its safety and clinical outcomes.² ³ ⁴ ⁶ ⁷

How is DCD Donor Heart Transplantation different from other heart transplant treatments?

DCD Donor Heart Transplantation involves using hearts from donors who have died due to circulatory death, which is different from the traditional method that uses hearts from brain-dead donors. This approach expands the donor pool and can reduce wait times for transplants.¹ ² ³ ⁴ ⁸

What is the purpose of this trial?

The purpose the research is to evaluate whether patients who receive a Donation after Circulatory Death (DCD) heart for cardiac transplantation using either normothermic regional perfusion (NRP) or direct procurement and perfusion (DPP) have similar outcomes as patients who receive Donation after Brain Death (DBD) heart using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center.

Research Team

Fardad Esmailian, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

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Timeline

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

Treatment Details

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.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: DCD Donor Heart TransplantationExperimental Treatment1 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 TransplantationExperimental Treatment1 Intervention

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