Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant (VALET-CMV)

September 22, 2025 updated by: Afsana Rahman, Columbia University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Adel T Alnatour, BS

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • NYP-Weill Cornell
        • Contact:
          • Adel T Alnatour, BS
        • Contact:
        • Principal Investigator:
          • David Majure, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University/NYP Milstein Hospital
        • Contact:
        • Contact:
          • Adel T Alnatour, BS
        • Principal Investigator:
          • Afsana Rahman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letermovir
Patients with moderate to high risk CMV risk will get letermovir for prophylaxis for 6 months for moderate risk and 1 year for high risk
Drug: Letermovir
CMV prophylaxis
Active Comparator: Valganciclovir
Patients with moderate to high risk CMV risk will get valganciclovir for prophylaxis for 6 months for moderate risk and 1 year for high risk. This is standard of care
Drug: Valganciclovir
Standard therapy for CMV prophylaxis
No Intervention: No treatment
Low risk CMV patients who do not have an indication for CMV prophylaxis will be monitored

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy)
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)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months after initiation of CMV prophylaxis
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.
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 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.
Within 6 months after completing CMV prophylaxis

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months to 1 year after initiating CMV prophylaxis
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.
6 months to 1 year after initiating CMV prophylaxis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2025

Primary Completion (Estimated)

January 17, 2028

Study Completion (Estimated)

January 17, 2029

Study Registration Dates

First Submitted

July 9, 2025

First Submitted That Met QC Criteria

July 18, 2025

First Posted (Actual)

July 23, 2025

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAV8422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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