The focus of investigation in the proposed study protocol is the rates of Cytomegalovirus viremia and/or disease in patients after heart transplantation undergoing novel CMV prophylaxis protocol using letermovir.
Conditions
Interventions
Trade Name: Prevymis
Product Name: Prevymis
Pharmaceutical Form: Film-coated tablet
Sponsors
University Medical Center Ljubljana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria will consist of the following: • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient exclusion criteria will consist of the following: • short-term mechanical circulatory support prior HTX • ongoing CMV infection/disease • D-/R- CMV serostatus • heart re-transplantation • need for intensified immunosuppression protocol o >20% cytolytic alloantibodies prior transplant o 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the efficacy of letermovir-based CMV prophylaxis in patients after heart transplantation. ;Secondary Objective: The secondary objectives of the study are: •to investigate the tolerability of letermovir-based CMV prophylaxis in patients after heart transplantation. •to explore the potential correlation between letermovir-based CMV prophylaxis and restitution of cell-regulated immunity in patients after heart transplantation.;Primary end point(s): The primary end-point of the proposed study will be the rate of early CMV infections/disease during virostatic prophylaxis.;Timepoint(s) of evaluation of this end point: All patients will be followed monthly on outpatient basis for 12 months after enrollment. At baseline, and at each follow-up, we will perform comprehensive clinical evaluation and data collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points of the proposed study are as follows: • The rate of leukopenia during virostatic prophylaxis, defined as number of patients who will develop at least one episode of leukopenia at any time during the study follow-up. • The rate of neutropenia during virostatic prophylaxis, defined as number of patients who will develop at least one episode of neutropenia at any time during the study follow-up. • The rate of late CMV infections/disease between virostatic discontinuation and 6 months thereafter. • The time-course of the restitution of cell-mediated immunity during virostatic prophylaxis • The rate of CMV resistance to virostatic therapy. ;Timepoint(s) of evaluation of this end point: All patients will be followed monthly on outpatient basis for 12 months after enrollment. At baseline, and at each follow-up, we will perform comprehensive clinical evaluation and data collection. | — |
Countries
Slovenia
Contacts
Public ContactDept. of Cardiology Research Office
University Medical Center Ljubljana
Outcome results
None listed