Design of a prospective observational survey on landiolol in atrial fibrillation/atrial flutter patients with chronic heart failure – AF-CHF landiolol survey

Abstract

BackgroundIn Japan, intravenous digoxin was previously recommended as a standard drug for acute control of the heart rate in atrial fibrillation (AF)/atrial flutter (AFL) patients with chronic heart failure (CHF). Treatment alternatives for such cases were limited and new drugs for this purpose are needed. In November 2013, landiolol hydrochloride (Onoact® 50 for Injection, Ono Pharamaceutical, Osaka, Japan) was approved with the indication for “tachyarrhythmia (AF/AFL) in patients with cardiac dysfunction.” However, clinical experience with this condition is still insufficient. Therefore, it is important to conduct a surveillance of landiolol under actual clinical settings. In addition, collecting data on the mid- and long-term outcomes in patients treated with landiolol which have not been collected in clinical trials are indispensable. MethodsThis prospective survey will involve patients treated with landiolol for the treatment of tachyarrhythmia (AF/AFL) in cardiac dysfunction at Japanese medical facilities from June 2014 to May 2017. The planned number of patients for analysis is approximately 500. The evaluations will be made not only to identify the adverse events and clinical effectiveness of the drug, but also to characterize the mid- and long-term outcomes of patients receiving and switching to oral-β-blockers after the discontinuation of landiolol. ResultsThis study was started in June 2014 (registration period 2 years, survey period 3 years) and will end in May 2017. ConclusionsThis survey will clarify both the characteristics and mid- and long-term outcome of using landiolol to treat AF/AFL patients with cardiac dysfunction in clinical practice. Moreover, this survey will simultaneously provide important data that will reveal the possible gap between clinical trials and clinical practice in these patients.