Landiolol for Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
Postoperative atrial fibrillation (POAF) is the most common arrhythmia after cardiac surgery
with incidences ranging from 20% to 40% with the consequence of increasing mortality,
morbidity, and hospital length of stay, as well as increasing the costs to the health care
system. To prevent POAF the use of beta-blockers is suggested by the EACTA and ESC
guidelines. Despite the prophylactic use, the discontinuation of beta-blockers in the
perioperative period is a known risk factor that contributes to the occurrence of POAF. Due
to the short half time and the highly beta-1-selective properties of Landiolol, it could be
possible to initiate a betablocker for prevention in the immediate postoperative setting,
without adverse effects like hypotension or severe bradycardia as seen with other
betablockers like Metoprolol or even sometimes Esmolol.
Landiolol is already approved for the treatment of atrial tachycardias but is not yet
approved for the use of prevention of POAF. In multiple previous studies the preventive
potential of Landiolol in cardiac surgery could be proven in japanese study populations, with
limitations due to limited sample sizes. In these trials the use of low-dose Landiolol
effectively reduced the incidence of POAF without significant differences of increased side
effects or in the hemodynamic stability compared to the placebo or standard of care groups.
The primary objective of this prospective, double-blind, randomized, placebo-controlled phase
III trial is to prove that the postoperative application of low-dose Landiolol significantly
reduces the incidence of POAF without increased adverse events or hemodynamic instability
compared to the placebo group after cardiac surgery in a non-Asian population.