Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant

Not Applicable

Recruiting

• Conditions: CMV Viremia; Heart Transplant Infection; Heart Transplant Failure and Rejection
• Interventions: Drug: Letermovir; Drug: Valganciclovir

• Registration Number: NCT07079735
• Lead Sponsor: Columbia University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Study Start: 2025-08-17
• Primary Completion: 2028-01-17
• Study Completion: 2029-01-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letermovir	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
Valganciclovir	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

Primary Outcome Measures

Name	Time	Method
Occurrence of leukopenia	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)
Occurrence of neutropenia	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 Outcome Measures

Name	Time	Method
Number of patients with any detectable CMV viremia after initiation of CMV prophylaxis	6 months after initiation of CMV prophylaxis	Number of patients with any positive CMV viral load detected by polymerase chain reaction (PCR)
Number of patients with any detectable CMV viremia while on CMV prophylaxis	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.
Number of patients with any detectable CMV viremia after completing CMV prophylaxis	Within 6 months after completing CMV prophylaxis	Number of patients with any positive CMV viral load detected by PCR.

Trial Locations

Locations (2)

NYP-Weill Cornell; 🇺🇸 New York, New York, United States

Columbia University/NYP Milstein Hospital; 🇺🇸 New York, New York, United States