NCT07079735 · Columbia University
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
(VALET-CMV)
What this study is about
The purpose of this study is to compare the safety and effectiveness of letermovir with valganciclovir for prevention of Cytomegalovirus (CMV) viremia in moderate to high risk serostatus heart transplant recipients.
View original scientific description
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.
Interventions
DRUG
Letermovir
CMV prophylaxis
DRUG
Valganciclovir
Standard therapy for CMV prophylaxis
Primary outcome measures
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)
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Collaborators
Cornell University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2025 · Source of record for eligibility and locations