Comparing Letermovir and Valganciclovir for CMV Prevention After Heart Transplant

This study is comparing two medications, letermovir and valganciclovir, to see which is safer and more effective at preventing Cytomegalovirus (CMV) infection after a heart transplant. CMV is a common virus that can cause serious problems for transplant patients. Valganciclovir is the standard treatment, but letermovir might have fewer side effects like low white blood cell counts (leukopenia) and low neutrophil counts (neutropenia). This study wants to see if letermovir works as well as valganciclovir in heart transplant patients, as it has in other transplant types. You may be able to join if you are over 18, have recently had a heart transplant, and have not yet started CMV prevention medicine. The study is currently recruiting about 150 participants.

Study design
This is a multi-center study where participants will be randomly assigned to receive either letermovir or valganciclovir. It aims to enroll 150 participants.
What's involved
Participants will receive CMV prophylaxis for up to 6 months for moderate risk or up to 12 months for high risk. Those receiving letermovir will also take acyclovir for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for leukopenia and neutropenia during the entire duration of CMV prophylaxis, which can be up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07079735

Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant

Recruiting
PHASE2Ages 18–99InterventionalPrevention
Columbia University
~150 participants
Updated 2025-09-25 on ClinicalTrials.gov
What's tested:LetermovirValganciclovir

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of leukopenia
Measured over During the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy)
+1 more outcome measured
CMV Viremia
Heart Transplant Infection
Heart Transplant Failure and Rejection

NCT07079735

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University/NYP Milstein Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

  • NYP-Weill Cornell

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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  • Occurrence of leukopeniaDuring the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy)

    Number of patients with leukopenia (white blood cell count \<3000 cells µL)

  • Occurrence of neutropeniaDuring the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk from start of therapy)

    Number of patients with neutropenia (absolute neutrophil count \<1500 cells/µL)