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

Primary Purpose

Atrial Fibrillation, Atrial Fibrillation Rapid, Acute Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Intensive heart rate control with landiolol
Standard approach to heart rate control
Sponsored by
Institute for Clinical and Experimental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring rate control, betablockers, landiolol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Clinical and Experimental Medicine (IKEM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive rate control with landiolol

Standard therapy

Arm Description

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

Standard heart rate control with therapy other than landiolol

Outcomes

Primary Outcome Measures

Heart rate control
Achievement of heart rate <115/min for at least 15 mins
Change in patient-reported symptoms
Change of patient-reported dyspnea evaluated 1-10 visual analog scale (1=unbearable dyspnea, 10=no symptoms)

Secondary Outcome Measures

Significant change of heart rate
Decrease of heart rate >20% from baseline
Heart rate and heart rhythm
the mean heart rate obtained from three measurements
Safety - hypotension
Occurence of hypotension requiring reduction of the dose of betablockers or vasopressors
Change in cardiac index
Change in cardiac index (L/m2) evaluated noninvasively by bioreactance (Starling SV, Cheetah Medical)
Change in stroke volume index
Change in stroke volume index (ml/m2) evaluated noninvasively by bioreactance (Starling SV, Cheetah Medical)

Full Information

First Posted
December 2, 2020
Last Updated
January 5, 2021
Sponsor
Institute for Clinical and Experimental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04694092
Brief Title
Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation
Acronym
LARISA
Official Title
Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Clinical and Experimental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: Eligible patients with signed consent will be enrolled. Baseline transthoracic echocardiography, laboratory testing, evaluation of subjective dyspnea, lung water by ultrasound, chest x-ray, hemodynamic monitoring (details below) Randomisation 1:1 to standard therapy vs. intensive heart rate control Two hours of therapy with continous hemodynamic monitoring (blood pressure by arterial line, cardiac output and stroke volume non-invasively by bioreactance) 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 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..) At 2 hours: evaluation of patients subjective dyspnea (primary clinical endpoint), heart rate (primary endpoint), hearth rhythm and hemodynamics After 2 hours, both groups can be treated according to the preference of the physician. Symptoms, heart rate control, hemodynamics and lung congestion will be reevaluated at 12 and 48 hours The study protocol will end after 48 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Fibrillation Rapid, Acute Heart Failure, Left Ventricular Dysfunction
Keywords
rate control, betablockers, landiolol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 1:1 to intensive rate control with landiolol vs. standard therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive rate control with landiolol
Arm Type
Experimental
Arm Description
Intensive heart rate control using landiolol with the goal to achieve HR<115 during the first 2 hours.
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Standard heart rate control with therapy other than landiolol
Intervention Type
Drug
Intervention Name(s)
Intensive heart rate control with landiolol
Other Intervention Name(s)
Rapibloc, Amomed Pharma, Austria
Intervention Description
Intensive heart rate control preferably with the use of short-acting betablocker landiolol in combination with digoxin
Intervention Type
Drug
Intervention Name(s)
Standard approach to heart rate control
Intervention Description
Standard heart rate control with intravenous or oral beta-blockers and/or antiarrhythmic in combination with digoxin
Primary Outcome Measure Information:
Title
Heart rate control
Description
Achievement of heart rate <115/min for at least 15 mins
Time Frame
during the first 2 hours
Title
Change in patient-reported symptoms
Description
Change of patient-reported dyspnea evaluated 1-10 visual analog scale (1=unbearable dyspnea, 10=no symptoms)
Time Frame
at 2 hours
Secondary Outcome Measure Information:
Title
Significant change of heart rate
Description
Decrease of heart rate >20% from baseline
Time Frame
During the first 2 hours
Title
Heart rate and heart rhythm
Description
the mean heart rate obtained from three measurements
Time Frame
heart rate measured at hours 2, 12 and 48 of the study protocol
Title
Safety - hypotension
Description
Occurence of hypotension requiring reduction of the dose of betablockers or vasopressors
Time Frame
first 2 hours
Title
Change in cardiac index
Description
Change in cardiac index (L/m2) evaluated noninvasively by bioreactance (Starling SV, Cheetah Medical)
Time Frame
evaluated between baseline and hour 2
Title
Change in stroke volume index
Description
Change in stroke volume index (ml/m2) evaluated noninvasively by bioreactance (Starling SV, Cheetah Medical)
Time Frame
evaluated between baseline and hour 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marek Sramko, MD., PhD.
Phone
+420776246127
Email
marek.sramko@ikem.cz
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine (IKEM)
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Sramko, MD, PhD
Phone
+420776246127
Email
marek.sramko@ikem.cz

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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