Clinical Research Directory

Inclusion Criteria: 1. The patient has provided informed consent 2. Age ≥18 years old at the time of consent 3. Heart transplant recipient between 2 months to 2 years post-transplant 4. Simultaneous dual-positive GEP/dd-cfDNA result, defined as both a dd-cfDNA level ≥0.20% AND one of the following: 1. a GEP score ≥30 (if 55-180 days post-transplant) 2. a GEP score ≥34 (if ≥181 days post-transplant) 5. An endomyocardial biopsy (EMB) showing no rejection \[(0R or 1R) and pAMR0\] AND both of the following: 1. Performed on the same day or up to 10 calendar days after the simultaneous dual-positive GEP/dd-cfDNA draw. 2. No intention to treat the subject empirically for ACR or AMR based on other clinical features, including clinically relevant DSA 6. If the closest GEP/dd-cfDNA result prior to screening was also dual positive, both of the following must be true: 1. GEP score OR dd-cfDNA level has increased from previous value 2. Neither GEP score nor dd-cfDNA level have decreased from previous value 7. Randomization within 14 calendar days of the simultaneous dual positive GEP/dd-cfDNA draw 8. All patients of childbearing potential must have a negative pregnancy test prior to randomization. Use of contraception must be followed per site standard clinical protocol. 9. Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: 1. Multiorgan or bone marrow transplant recipient 2. On an organ transplant waitlist at the time of screening 3. In-patient at the time of study screening 4. Presence of an active infection being treated with an antibiotic, antifungal, and/or antiviral or malignancy 5. Random capillary blood glucose of \>180 mg/dL on day of enrollment 6. Enrollment in another interventional study or exposed to experimental drug in the last 30 days 7. LVEF \<55% on the most recent echocardiogram 8. Most recent EMB before screening showing ACR (≥2R) and/or AMR (≥pAMR1) 9. Intent to transfer heart transplant care to another center in the 12-months after randomization 10. Patient who, in the opinion of the treating provider or Investigator, is not an appropriate candidate for study participation due to safety concerns, medical judgment, or other clinical considerations. 11. Patient receiving steroids at a dose equivalent to ≥25 mg/day 12. Clinical or hemodynamic concern for rejection-related heart failure, as determined by the treating clinician 13. Patient receiving granulocyte colony stimulating factor (GCSF) within the past 30 days