Letermovir versus valganciclovir to prevent CMV after heart transplant
VALganciclovir vs. LETermovir for Primary Prevention of CMV in Moderate to High-Risk Heart Transplant Recipients (The VALET-CMV Study)
This trial will test whether letermovir or valganciclovir better prevents CMV viremia in adults at moderate-to-high CMV risk after a heart transplant.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT07079735 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective, randomized two-arm study comparing letermovir to valganciclovir as primary CMV prophylaxis in adult heart transplant recipients at moderate-to-high serostatus risk. Participants will be randomized to receive letermovir (with acyclovir for HSV prophylaxis for six months) or valganciclovir and will be followed for CMV viremia, CMV disease, and safety outcomes including leukopenia and neutropenia. Low-risk patients will be monitored observationally to better characterize CMV outcomes in that group. The trial is designed to confirm whether letermovir provides similar protection against CMV with a more favorable blood-count safety profile compared with valganciclovir in the heart transplant population.
Who should consider this trial
Good fit: Adults aged 18 or older who have just received a heart transplant, are moderate-to-high CMV serostatus risk, and have not yet started CMV prophylaxis.
Not a fit: Patients with recent or suspected CMV disease within the prior six months, those who have already started CMV prophylaxis, or those at low CMV risk are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, letermovir could prevent CMV viremia after heart transplant while reducing rates of leukopenia and neutropenia compared with valganciclovir.
How similar studies have performed: Previous studies in kidney, lung, and hematopoietic stem cell transplant populations have shown letermovir to be non-inferior to valganciclovir with substantially less leukopenia and neutropenia, but prospective data in heart transplant recipients are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York and 1 other locations
- NYP-Weill Cornell — New York, New York, United States (Recruiting)
- Columbia University/NYP Milstein Hospital — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Afsana Rahman, MD
- Email: ar3262@cumc.columbia.edu
- Phone: 2123054600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.