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

NCT04694092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-01-06

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation
  • Atrial Fibrillation Rapid
  • Acute Heart Failure
  • Left Ventricular Dysfunction

Interventions

DRUG

Intensive heart rate control with landiolol

Intensive heart rate control preferably with the use of short-acting betablocker landiolol in combination with digoxin

DRUG

Standard approach to heart rate control

Standard heart rate control with intravenous or oral beta-blockers and/or antiarrhythmic in combination with digoxin

Sponsors & Collaborators

  • Institute for Clinical and Experimental Medicine

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Czechia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04694092 on ClinicalTrials.gov