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

Columbia University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Heart Transplant Failure and Rejection; CMV Viremia; Heart Transplant Infection

Treatments: Drug: Valganciclovir; Drug: Letermovir

Study type: Interventional

Funder types: Other

Identifiers

NCT07079735

AAAV8422

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Letermovir

Experimental group

Description:

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

Treatment:

Drug: Letermovir

Valganciclovir

Active Comparator group

Description:

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

Treatment:

Drug: Valganciclovir

No treatment

No Intervention group

Description:

Low risk CMV patients who do not have an indication for CMV prophylaxis will be monitored