Preventing CMV infection in heart transplant patients with Letermovir
Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients: A Non-randomized Cohort Pilot Study
This study is testing if a new medication called Letermovir can help prevent CMV infections in heart transplant patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT05432778 on ClinicalTrials.gov |
What this trial studies
This Phase II pilot study aims to evaluate the efficacy of Letermovir as a prophylactic treatment for cytomegalovirus (CMV) infection in heart transplant recipients. The study will enroll 30 patients who have recently undergone heart transplantation and will receive Letermovir, while 60 historical controls will receive valgancyclovir for comparison. Prophylaxis will begin between days 4 and 7 post-transplant, and the duration will be guided by specific CMV assay results. The study seeks to determine if Letermovir can effectively reduce the incidence of CMV-related complications in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are new heart transplant recipients at moderate to high risk for CMV infection.
Not a fit: Patients with ongoing CMV infection or those with a D-/R- CMV serostatus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of CMV infections and associated complications in heart transplant recipients.
How similar studies have performed: Previous studies have shown that antiviral prophylaxis can be effective in preventing CMV infections in transplant populations, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * heart transplant recipient (new) * moderate (D+/R+ and D-/R+) or high (D+/R-) risk CMV serostatus * signed informed consent for participation in the study Exclusion Criteria: * short-term mechanical circulatory support prior HTX * ongoing CMV infection/disease * D-/R- CMV serostatus * heart re-transplantation * need for intensified immunosuppression protocol * \>20% cytolytic alloantibodies prior transplant * perioperative (within 7 days after HTX) allograft rejection \> 1R * immunoinduction with ATG * pregnancy * active participation in another interventional clinical trial * know hypersensitivity to letermovir * known hypersensitivity to valgancyclovir * known hematological disorders (apart from anemia)
Where this trial is running
Ljubljana
- University Medical Center Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: Bojan Vrtovec, MD, PhD — Advanced Heart Failure and Transplantation Center, Universtiy Medical Center Ljubljana, Slovenia
- Study coordinator: Bojan Vrtovec, MD, PhD
- Email: bojan.vrtovec@kclj.si
- Phone: +38615222844
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.