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NCT Number: NCT07079735

Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant

The purpose of this study is to compare the safety and efficacy of letermovir with valganciclovir for prevention of Cytomegalovirus (CMV) viremia in moderate to high risk serostatus heart transplant recipients.

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Key information

Conditions

CMV Viremia Behavior Heart Transplant Failure and Rejection Heart Transplant Infection Rejection, Psychology Social Behavior

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Columbia University/NYP Milstein Hospital, New York, United States

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About this study

This trial is a multi-center prospective, two-arm randomized study designed to assess the safety of letermovir use as the primary prophylaxis for CMV in patients recently transplanted with a heart. Although there are findings to support the safety and efficacy profiles of letermovir in certain patient populations (kidney transplant, lung transplant, and hematopoetic stem cell transplant), there is a clear lack of prospective data to support use of letermovir at the primary prevention of CMV for patients recently transplanted with a heart. Thus, despite numerous studies showing letermovir to be non-inferior to valganciclovir with a substantial reduction in leukopenia and neutropenia, valganciclovir continues to be the initial CMV prophylaxis in heart transplant recipients. This study aims to either confirm the findings about letermovir as seen in other patient populations, or to highlight potential concerns about using letermovir in heart transplant patients. Patients who get letermovir will also be given acyclovir for HSV (Herpes Simplex Virus) prophylaxis for 6 months. Those taking valganciclovir will not need this as HSV is covered by valganciclovir. Low risk patients will also be monitored during this period for a better understanding of CMV disease in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who are >18 years of age who have received a heart transplant and have not started their CMV prophylaxis regimen will be included.

Exclusion criteria

History of or suspected CMV disease within 6 months prior is excluded.

Treatment and study plan

Letermovir

Drug

CMV prophylaxis

Valganciclovir

Drug

Standard therapy for CMV prophylaxis

Primary outcomes

  1. Occurrence of leukopenia

    Time frame: During 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)

  2. Occurrence of neutropenia

    Time frame: During 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)

Secondary outcomes

  1. Number of patients with any detectable CMV viremia after initiation of CMV prophylaxis

    Time frame: 6 months after initiation of CMV prophylaxis

    Number of patients with any positive CMV viral load detected by polymerase chain reaction (PCR)

  2. Number of patients with any detectable CMV viremia while on CMV prophylaxis

    Time frame: During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk patients)

    Number of patients with any positive CMV viral load detected by PCR.

  3. Number of patients with any detectable CMV viremia after completing CMV prophylaxis

    Time frame: Within 6 months after completing CMV prophylaxis

    Number of patients with any positive CMV viral load detected by PCR.

Other outcomes

  1. Percent of CD4 and CD8 T cells that respond to CMV antigen

    Time frame: 6 months to 1 year after initiating CMV prophylaxis

    Exploratory: looking at T cell unity against CMV. Assessing the predictive attributes of a positive test on the chance of future CMV viremia or disease.

  2. Viral load of the torque teno virus (TTV)

    Time frame: 6 months to 1 year after initiating CMV prophylaxis

    Exploratory: TTV activity will be measured by the TTV assay. This will be used to assess the immunogenicity of heart transplant patients that are identified as being at increased risk of infection or rejection.

Study contacts

Contact information is provided by the study sponsor or research team.

Adel T Alnatour, BS

CONTACT

Afsana Rahman, MD

CONTACT

[email protected]

2123054600

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Cornell University

Registry information

Official study title

VALganciclovir vs. LETermovir for Primary Prevention of CMV in Moderate to High-Risk Heart Transplant Recipients (The VALET-CMV Study)

Acronym: VALET-CMV

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 23, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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