VALganciclovir vs. LETermovir for Primary Prevention of CMV in Moderate to High-Risk Heart Transplant Recipients (The VALET-CMV Study)
Columbia University
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.
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…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DrugLetermovir
CMV prophylaxis
- DrugValganciclovir
Standard therapy for CMV prophylaxis
Locations (2)
- NYP-Weill CornellNew York, New York
- Columbia University/NYP Milstein HospitalNew York, New York