Valganciclovir vs Letermovir for Primary Prevention of CMV in Moderate to High-Risk Heart Transplant Recipients

What this Trial Is About

Researchers are evaluating the safety and effectiveness of letermovir compared to valganciclovir for preventing Cytomegalovirus (CMV) in heart transplant patients who are at moderate to high risk of CMV viremia. This study addresses the lack of prospective data on letermovir as the first preventive treatment for CMV in recent heart transplant recipients, despite evidence supporting its use in other transplant types. It aims to either confirm letermovir's safety and effectiveness or identify potential concerns in this specific patient group. The trial is a multi-center, randomized study with two main groups: one receives letermovir and the other valganciclovir. Patients at moderate risk will receive prophylaxis for 6 months, while those at high risk will be treated for 1 year. Patients given letermovir will also take acyclovir to prevent Herpes Simplex Virus (HSV) for 6 months, whereas those on valganciclovir do not need additional HSV prevention. Low-risk patients who do not require CMV prophylaxis will be monitored to better understand CMV disease in this group. Participants will be monitored throughout their treatment periods, including blood tests to check for leukopenia and neutropenia during prophylaxis. Researchers will also track the presence of CMV in the blood during and after treatment. The study includes regular assessments to evaluate safety and treatment effects for up to a year, with follow-up visits to observe CMV viremia after prophylaxis ends. The total participation time can range from 6 months to 1 year depending on risk level.

Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant