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Cedars-Sinai Heart Institute is currently conducting the following Heart Transplant Research trials:
- The De-novo Use of Eculizumab Alongside Conventional Therapy in Presensitized Patients Receiving Cardiac Transplantation: An Open-Label, Investigator-Initiated
The De-novo Use of Eculizumab Alongside Conventional Therapy in Presensitized Patients Receiving Cardiac Transplantation: An Open-Label, Investigator-Initiated
Pilot Trial: [The DUET Cardiac Trial]
IRB Approval No.: 28970
Contact: Sean Sana, Study Coordinator, 310-248-7129
Project Summary: The growing proportion of sensitized cardiac recipients presents an additional challenge to the transplant practitioner attempting to minimize the occurrence of antibody mediated rejection (AMR). Patients pre-exposed or "sensitized" to antigen exposing events (i.e.: blood transfusions, multiple pregnancies, prior organ transplantations, ventricular support devices) are more likely to both possess preformed and develop de-novo antibodies. Sensitized patients with panel reactive antibodies > 25% are at risk for increased mortality after heart transplantation. A central component of antibody-mediated cell injury is complement activation. The inhibition of terminal complement activation may be the missing link to decreasing possibly both complement-mediated AMR and cellular rejection (CR) by inhibiting both the inflammatory effects of both circulating antibodies and cytokine induced cell death. Eculizumab is a monoclonal antibody that specifically binds to complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. By this mechanism, eculizumab (Soliris®) inhibits terminal complement mediated intravascular hemolysis in paroxysmal nocturnal hemoglobinuria patients. This study is a non-randomized, open-label, investigator-initiated safety and efficacy trial investigating the de-novo use of eculizumab alongside conventional therapy to prevent antibody mediated rejection. The duration of the study will include an open enrollment period and at least 12 months of follow-up (post-transplant). The trial will enroll a total of up to 10 "sensitized" patients with a panel reactive antibody score of greater than 70% and not previously or currently enrolled in another ongoing trial. At the time of initial baseline screening prior to transplantation, patients willing to consent to the investigational use of eculizumab will be enrolled in the treatment arm (comprising a maximum of 10 patients). The use of eculizumab will be un-blinded to all study and research practitioner participants. A historical cohort of 10 additional patients will also be utilized for comparison.