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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Treatments: Landiolol

Criteria

Inclusion Criteria:

• acute heart failure with reduced left ventricular ejection (<40%)

• atrial fibrillation with heart rate >130/min lasting presumably >12 hours and presumably contributing to the acute heart failure

• pulmonary congestion detected by auscultation, lung ultrasound or CXR

Exclusion Criteria:

• ongoing type 1. myocardial infarction

• cardiogenic shock

• presumed need for mechanical heart support during the first 48hours of the study

• presumed need for electric cardioversion during the first 2 hours of the study

• medication for heart rate control (beta-blockers, calcium channel blockers, digoxin) or antiarrhythmics introduced <24 hours before the study. Chronic therapy with these will not be a contraindication for the study

• thyreotoxicosis