VALganciclovir vs. LETermovir for Primary Prevention of CMV in Moderate to High-Risk Heart Transplant Recipients (The VALET-CMV Study)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Patients who are \>18 years of age who have received a heart transplant and have not started their CMV prophylaxis regimen will be included.
Locations
United States
New York
Columbia University/NYP Milstein Hospital
RECRUITING
New York
NYP-Weill Cornell
RECRUITING
New York
Contact Information
Primary
Afsana Rahman, MD
ar3262@cumc.columbia.edu
2123054600
Backup
Adel T Alnatour, BS
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2029-01-17
Participants
Target number of participants: 150
Treatments
Experimental: 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
Active_comparator: 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
No_intervention: No treatment
Low risk CMV patients who do not have an indication for CMV prophylaxis will be monitored
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: Cornell University