drugset / Trial / NCT04223739

Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery

NCT04223739

Phase 4 Unknown 380 enrolled University Hospital, Caen
RandomizedParallel-groupOpen-labelTreatment

Summary

Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias. Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study. The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.

Timeline

Start
2019-12-13
Primary completion
2021-06-01
Completion
2022-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amiodarone Small molecule 1 g Other
Comparator Landiolol Small molecule 80 ug/kg Other

Indications