drugset / Trial / NCT04694092

Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation

NCT04694092

RandomizedParallel-groupOpen-labelTreatment

Summary

The study will include patients with acute heart failure with reduced left ventricular ejection fraction (\<40%) triggered by atrial fibrillation (AF) with a heart rate of \>130/min. Patients in cardiogenic shock, critical state, or patients requiring emergent electric cardioversion during the first 2 hours will be excluded. The patients will be randomized (1:1) to a strategy of initial intensive heart rate control using continuous infusion of landiolol and boluses of digoxin vs. standard approach to the rate control without the use of landiolol. All patients will receive recommended pharmacotherapy of acute heart failure (diuretics, nitrates, inotropes in patients with signs of low cardiac output - preferentially milrinone or levosimendan). The patients will undergo hemodynamic monitoring, laboratory testing, evaluation of symptoms, and quantification of lung water content by ultrasound for 48 hours. The study will test a hypothesis whether patients treated with initial intensive heart rate control with the preferential use of landiolol will achieve faster heart rate control, compensation of heart failure, and relief of heart failure symptoms without causing hypotension or deterioration of heart failure.

Timeline

Start
2020-11-05
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Landiolol Small molecule
Comparator Digoxin Other / unclassified 250 mg
Comparator Digoxin Other / unclassified 500 mg