Actively Recruiting
Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients: A Non-randomized Cohort Pilot Study
Led by University Medical Centre Ljubljana · Updated on 2023-11-09
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cytomegalovirus (CMV) infection is a common complication after heart transplantation, affecting up to 40-60% of recipients, usually within the first six months. While often asymptomatic, CMV can cause serious illness and increase risks like graft loss, cancers, and infections. This study aims to evaluate the effects of letermovir, a newer antiviral drug, for CMV prevention in heart transplant patients, as it has shown promise with fewer side effects in other transplant types. This Phase II pilot study will enroll 30 new heart transplant recipients who will receive letermovir as CMV prophylaxis. The drug will be given orally at 240 mg or 480 mg once daily, starting between days 4 and 7 post-transplant. The duration of treatment will be guided by blood tests measuring CMV immune response and viral load. A control group of 60 matched patients will receive the standard valgancyclovir treatment. Both groups will also receive standard immunosuppression and prophylaxis for fungal and pneumocystis infections. Participants will be monitored monthly for 12 months after enrollment, with evaluations including CMV infection rates, immune function tests, and side effect assessments like blood counts. If CMV infection occurs, treatment with valgancyclovir or gancyclovir will be given. After the study, patients still needing CMV prophylaxis will switch to standard care. The study will assess how well letermovir prevents CMV and its tolerability in heart transplant patients.
CONDITIONS
Brief Title
Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New heart transplant recipient
- Moderate or high risk CMV serostatus (D+/R+, D-/R+, or D+/R-)
- Signed informed consent for participation
You will not qualify if you...
- Short-term mechanical circulatory support before heart transplant
- Current active CMV infection or disease
- CMV serostatus D-/R-
- Heart re-transplantation
- Need for intensified immunosuppression protocol
- More than 20% cytolytic alloantibodies before transplant
- Allograft rejection greater than 1R within 7 days after transplant
- Immunoinduction with ATG
- Pregnancy
- Active participation in another interventional clinical trial
- Known allergy to letermovir
- Known allergy to valgancyclovir
- Known blood disorders other than anemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive virostatic prophylaxis with letermovir starting between days 4 and 7 after heart transplantation. The duration of prophylaxis is determined by the Quantiferon-CMV assay results and may continue up to 12 months.
Monthly outpatient visits for 12 months
Trial Site Locations
Total: 1 location
1
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
B
Bojan Vrtovec, MD, PhD
G
Gregor Poglajen, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here