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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
164
continous 2mcg/kg/min low dose application of Landiolol HCl for 72 hours
continous application of isotone saline solution for 72 hours
University Hospital Vienna
Vienna, Austria
RECRUITINGThe primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery
Death from any reason or the occurence of atrial in the holter ecg within 3 days after operation.
Time frame: 3 days
Incidence/ frequency of occurrence of atrial fibrillation during the first seven days after cardiac surgery
The occurence of AF in the holter ecg in the 7 days after the operation
Time frame: 7 days
Hemodynamic stability during treatment with IMP
Hemodynamic stability assessed with the need for vasoactive medication in the two groups within 7 days after operation
Time frame: 7 days
Length of ICU stay
Postoperative length of stay in days in the icu
Time frame: 30 days
Requirement of intensive respiratory and circulatory support
Length of invasive ventilation in hours or need for circulatory support
Time frame: 30 days
Peri- and postoperative mortality
Peri- and postoperative mortality
Time frame: 30 days
Assessment of biomarkers as surrogate parameters for cardiac dysfunction
Assessment of cardiac biomarkers to evaluate cardiac dysfunction
Time frame: 30 days
Biomarker Assessment for cardiac injury, remodelling and fibrosis
Biomarker assessment (TropT, CK, CK-MB, sST-2) for cardiac remodelling, fibrosis, apoptosis and ischemia reperfusion injury at time of start of the surgery, at ICU admission, 24 hours after ICU admission, 3 days and 7 days after surgery.
Time frame: 7 days
Incidence of serious adverse events
Incidence of serious adverse events
Time frame: 30 days
Echocardiographic assessment for left ventricular function
Echocardiographic assessment for left ventricular systolic, diastolic and valvular function 7 days after surgery
Time frame: 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.