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

NCT04694092 | Unknown

• 1 other identifier: LARISA2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rate control; betablockers; landiolol

Outcome Measures

Primary Outcomes (2)

• Heart rate control

  Achievement of heart rate \<115/min for at least 15 mins

  during the first 2 hours

• Change in patient-reported symptoms

  Change of patient-reported dyspnea evaluated 1-10 visual analog scale (1=unbearable dyspnea, 10=no symptoms)

  at 2 hours

Secondary Outcomes (5)

• Significant change of heart rate

  During the first 2 hours

• Heart rate and heart rhythm

  heart rate measured at hours 2, 12 and 48 of the study protocol

• Safety - hypotension

  first 2 hours

• Change in cardiac index

  evaluated between baseline and hour 2

• Change in stroke volume index

  evaluated between baseline and hour 2

Study Arms (2)

Intensive rate control with landiolol

EXPERIMENTAL

Intensive heart rate control using landiolol with the goal to achieve HR\<115 during the first 2 hours.

Drug: Intensive heart rate control with landiolol

Standard therapy

ACTIVE COMPARATOR

Standard heart rate control with therapy other than landiolol

Drug: Standard approach to heart rate control

Interventions

Intensive heart rate control with landiolol DRUG

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

Also known as: Rapibloc, Amomed Pharma, Austria

Intensive rate control with landiolol

Standard approach to heart rate control DRUG

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

Standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14021, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Ventricular Dysfunction, Left

Interventions

landiolol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Central Study Contacts

Marek Sramko, MD., PhD.

CONTACT

+420776246127; marek.sramko@ikem.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Acute Cardiology

Model Details: Patients will be randomized 1:1 to intensive rate control with landiolol vs. standard therapy

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 5, 2021
• Study Start: November 5, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

CZ (1)