Landiolol hydrochloride for Postoperative atrial fibrillation | Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Male or female patients ≥ 18 years old"}
• {"criterion_text":"- Written informed consent from patient"}
• {"criterion_text":"- Patients are in sinus rhythm"}
• {"criterion_text":"- Oral Betablocker in the patients long-term medication"}
• {"criterion_text":"- One of the following cardiac surgical procedures which is planned on cardiopulmonary bypass (CPB): a. Single valve surgery b. Single or multiple CABG procedures c. Single valve surgery in combination with one or multiple coronary artery bypass grafts (CABGs) d. Multiple valve surgery in combination with or without CABG e. Single or multiple valve surgery in combination with ascending aorta procedure with or without additional CABG f. Re-surgery of aortic valve, mitral valve, aortic arch or ascending aorta with or without CABG"}
• {"criterion_text":"- Cardiac surgery is performed electively"}

Exclusion criteria

• {"criterion_text":"- Bodyweight > 101kg and/or BMI ≥ 40"}
• {"criterion_text":"- Requiring inotropic, vasopressor or requiring ventilatory support at time of screening"}
• {"criterion_text":"- Circulatory shock requiring mechanical circulatory support before initiation of study medication"}
• {"criterion_text":"- Distributive shock (cardiac index>2.2 L/min with norepinephrine dose > 0.3 µg/kg/min to reach mean arterial pressure > 65mmHg) before initiation of study medication"}
• {"criterion_text":"- More than 5 units of RBC necessary to maintain a haemoglobin level >8mg/dl at the end of surgery"}
• {"criterion_text":"- Prior cardiac surgery within the past 6 months"}
• {"criterion_text":"- History of heart transplantation or planned heart transplantation"}
• {"criterion_text":"- Any other disease or condition that is likely to interfere with the evaluation of the study drug, outcome assessment or satisfactory conduct of the study: a. Active infective endocarditis b. Stroke or transient ischemic attack (TIA) within the last 6 months c. Concomitant disease with a life expectancy of less than 6 months d. Cardiopulmonary resuscitation within the last 4 weeks e. Patients requiring renal replacement therapy"}
• {"criterion_text":"- Active infection on current systemic antibiotics and/ or temperature greater than 38°C at time of screening and before start of surgery"}
• {"criterion_text":"- Haemoglobin < 5 mmol/l (< 8.06 g/dl)"}
• {"criterion_text":"- Any systemic anti-cancer therapy within past 3 months"}
• {"criterion_text":"- Cardiac surgery is planned as minimally invasive procedure (e.g., without thoracotomy or with lateral incision, minimal thoracotomy) or planned as off-pump surgery"}
• {"criterion_text":"- Patients with known hypersensitivity to any constituent of the IMP"}
• {"criterion_text":"- General exclusion criteria: a. Pregnant (in women of childbearing potential a urine or blood pregnancy test has to be performed) or breast-feeding women. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial b. Participation in any interventional clinical trial within the last one-month prior randomization in this clinicaltrial (screening failures can be rescreened, if appropriate) c. Alcohol, drug, or medication abuse d. Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, subinvestigators, or study nurse) or relationship to the sponsor"}
• {"criterion_text":"- Planned maze procedure, radiofrequency ablation, pulmonary vein ablation, resection of the atrial appendix or atrial resections during the surgery"}
• {"criterion_text":"- Sinus bradycardia (resting heart rate < 50/min) at screening and before start of IMP treatment"}
• {"criterion_text":"- Second- or third-degree atrioventricular block at screening and before start of IMP treatment"}
• {"criterion_text":"- Clinical hypothyroidism or hyperthyroidism at screening"}
• {"criterion_text":"- History of ventricular arrhythmia"}
• {"criterion_text":"- Permanent atrial fibrillation or atrial fibrillation at time of screening and IMP administration"}
• {"criterion_text":"- Emergency cardiac surgery"}

Primary endpoints

• {"endpoint_text":"- The primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery.","definition_or_measurement_approach":"Combined occurrence of atrial fibrillation and mortality measured during the initial 72-hour period after surgery (i.e., incidence of AF and deaths within 72 hours post-surgery)."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of atrial fibrillation during the initial seven days after surgery • Initiation of standard of care for atrial fibrillation because of postoperative atrial fibrillation • Hemodynamic stability assessed by systolic blood pressure, diastolic blood pressure, and heart rate (in patients on pacing, the pacemaker will be stopped before measurement of blood pressure and heart rate) at time of admission to the intensive care unit (ICU), at 24, 48 and 72 hours and 7 days after administr","definition_or_measurement_approach":"Occurrence of atrial fibrillation recorded during the first seven days post-surgery; initiation of standard-of-care treatment for postoperative AF; hemodynamic stability assessed by systolic and diastolic blood pressure and heart rate measured at ICU admission and at 24, 48, 72 hours and 7 days after administration."}

Austria

Earliest CTIS Part Ii Submission Date

07-01-2025

Latest Decision Or Authorization Date

27-01-2025

Processing Time Days

20

Number Of Sites

1

Number Of Participants

164

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"","full_name":"Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Medical University Vienna","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"AOP Orphan Pharmaceuticals GmbH","duties_or_roles":"Source of monetary support","organisation_type":""}