MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation

Condition(s) studied

Investigational drug(s) / intervention(s)

ICA: Patients will undergo annual CAV surveillance with ICA

PET: Patients will undergo annual CAV surveillance with PET

Study summary

Cardiac allograft vasculopathy (CAV) is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. Surveillance for CAV is vital; however an ideal approach has not been established. The goal of this study is to assess whether noninvasive positron emission tomography (PET) based surveillance is non-inferior to invasive coronary angiography (ICA) surveillance.

Eligibility

Primary outcome measure(s)

• Clinically relevant composite: Death — From date of randomization up to a minimum of 2 years
  Date of death due to any cause
• Clinically relevant composite: Retransplant — From date of randomization up to a minimum of 2 years
  Heart retransplantation for any indication
• Clinically relevant composite: Allograft Dysfunction — From date of randomization up to a minimum of 2 years
  ≥25% decrease in left ventricular ejection fraction
• Clinically relevant composite: CAV with Heart Failure or Myocardial Infarction — From date of randomization up to a minimum of 2 years
  Angiographic evidence of CAV (ISHLT CAV 1-3)

Trial sites (5)

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