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

NCT ID: NCT04694092

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2023-12-31

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.

Detailed Description

Procedure:

1. Eligible patients with signed consent will be enrolled.

2. Baseline transthoracic echocardiography, laboratory testing, evaluation of subjective dyspnea, lung water by ultrasound, chest x-ray, hemodynamic monitoring (details below)

3. Randomisation 1:1 to standard therapy vs. intensive heart rate control

4. Two hours of therapy with continous hemodynamic monitoring (blood pressure by arterial line, cardiac output and stroke volume non-invasively by bioreactance)

1. Standard therapy (oral or intravenous beta-blockers other than landiolol while avoiding hypotension or deterioration of hemodynamics, according to the preference of the physician) with a bolus of 250-500mg of digoxin

2. Intensive heart rate control with the goal to achieve heart rate <115 during the first the hours, preferentially with continuous infusion of landiolol and a bolus of 250-500mg of digoxin. The dose will be titrated according to the actual heart rate and hemodynamic parameters (blood pressure, cardiac index, stroke volume index). If possible, in both groups, electric cardioversion will be preferentially delayed during the first 2 hours. Both groups will receive standard therapy of acute heart failure (diuretics, inotropes if needed-preferentially milrinone or levosimendan, nitrates..)

5. At 2 hours: evaluation of patients subjective dyspnea (primary clinical endpoint), heart rate (primary endpoint), hearth rhythm and hemodynamics

6. After 2 hours, both groups can be treated according to the preference of the physician.

7. Symptoms, heart rate control, hemodynamics and lung congestion will be reevaluated at 12 and 48 hours

8. The study protocol will end after 48 hours.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive rate control with landiolol

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

Group Type: EXPERIMENTAL

Intensive heart rate control with landiolol

Intervention Type: DRUG

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

Standard therapy

Standard heart rate control with therapy other than landiolol

Group Type: ACTIVE_COMPARATOR

Standard approach to heart rate control

Intervention Type: DRUG

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

Interventions

Intensive heart rate control with landiolol

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

Intervention Type: DRUG

Standard approach to heart rate control

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

Intervention Type: DRUG

Other Intervention Names

Rapibloc, Amomed Pharma, Austria

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marek Sramko

Head of the Department of Acute Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute for Clinical and Experimental Medicine (IKEM)

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Marek Sramko, MD., PhD.

Role: CONTACT

marek.sramko@ikem.cz

+420776246127

Facility Contacts

Marek Sramko, MD, PhD

Role: primary

marek.sramko@ikem.cz

+420776246127

Other Identifiers

LARISA2020

Identifier Type: -

Identifier Source: org_study_id