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Study identifier: NCT05432778 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients

Condition: CMV Viremia  ·  Sponsor: University Medical Centre Ljubljana

PhasePhase 2
Planned participants90
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

CMV infection is the most prevalent infection after heart transplantation (HTX), occurring in up to 40-60% of the recipients. It most frequently occurs within the first 6 months after transplantation and commonly presents as an asymptomatic viral replication. Viral syndrome or tissue-invasive disease (gastroenteritis, pneumonitis, myocarditis or meningitis) are much less common. Even though CMV infection is generally treatable with virostatic therapy and/or CMV-specific immunoglobulins, direct effects of CMV infection (viral syndrome and tissue-invasive disease) and general and transplant-specific indirect effects of CMV infection have been associated with significant morbidity and mortality in HTX patient population, mainly due to graft loss, development of malignancies, or opportunistic infections. According to the latest consensus paper on CMV prophylaxis and treatment in solid organ transplant recipients, valgancyclovir (or its active form gancyclovir) represents a virostatic therapy of choice for CMV prophylaxis and treatment after HTX. However, valgancyclovir has an array of side effects including hematological (leukopenia, neutropenia, anemia, thrombocytopenia), neurologic (headache, insomnia), gastrointestinal (decreased appetite, diarrhea, vomiting and dyspepsia) and psychiatric (depression) disorders. These can either expose HTX patients to additional complications (e.g. leukopenia and/or neutropenia can result in systemic fungal infections), decrease patients' qual…

This description comes directly from the study's public registry record.

Talk to the study team

Bojan Vrtovec, MD, PhD  ·  +38615222844  ·  bojan.vrtovec@kclj.si

Gregor Poglajen, MD, PhD  ·  +38615228671  ·  gregor.poglajen@kclj.si

Always discuss trial participation with your own doctor first.

Locations (1)

University Medical Center LjubljanaLjubljana, SloveniaRecruiting

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Source record: clinicaltrials.gov/study/NCT05432778