Atrial FibrillationLARISANCT04694092
Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation
A study of Atrial Fibrillation and Atrial Fibrillation Rapid, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation Rapid, Acute Heart Failure
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Nov 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 14021
Marek Sramko, MD, PhD, +420776246127, marek.sramko@ikem.cz
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Atrial Fibrillation Rapid, Acute Heart Failure, Left Ventricular Dysfunction
- Being tested
- Intensive heart rate control with landiolol, Standard approach to heart rate control
- Keywords
- rate control, betablockers, landiolol
- Medical subject headings
- Atrial Fibrillation, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive heart rate control with landiololDrug
Also called Rapibloc, Amomed Pharma, Austria
Intensive heart rate control preferably with the use of short-acting betablocker landiolol in combination with digoxin
Standard approach to heart rate controlDrug
Standard heart rate control with intravenous or oral beta-blockers and/or antiarrhythmic in combination with digoxin
| Study group | Role | What they receive |
|---|---|---|
| Intensive rate control with landiolol | Experimental | Intensive heart rate control using landiolol with the goal to achieve HR<115 during the first 2 hours. Receives: Drug: Intensive heart rate control with landiolol |
| Standard therapy | Active comparator | Standard heart rate control with therapy other than landiolol Receives: Drug: Standard approach to heart rate control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate control
Achievement of heart rate <115/min for at least 15 mins
Measured: 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)
Measured: at 2 hours
Secondary outcomes (5)
Significant change of heart rate
Decrease of heart rate >20% from baseline
Measured: During the first 2 hours
Heart rate and heart rhythm
the mean heart rate obtained from three measurements
Measured: heart rate measured at hours 2, 12 and 48 of the study protocol
Safety - hypotension
Occurence of hypotension requiring reduction of the dose of betablockers or vasopressors
Measured: first 2 hours
Change in cardiac index
Change in cardiac index (L/m2) evaluated noninvasively by bioreactance (Starling SV, Cheetah Medical)
Measured: evaluated between baseline and hour 2
Change in stroke volume index
Change in stroke volume index (ml/m2) evaluated noninvasively by bioreactance (Starling SV, Cheetah Medical)
Measured: evaluated between baseline and hour 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start5 Nov 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to intensive rate control with landiolol vs. standard therapy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marek Sramko, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694092
- Sponsor's protocol ID
- LARISA2020
- Acronym
- LARISA
- Status last verified
- Jan 2021
- First submitted
- 2 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sramko M, Benak A, Toman J, Kleissner M, Pazdernik M, Kautzner J. Landiolol for rate control in decompensated heart failure due to atrial fibrillation: the LARISA trial. Eur Heart J Acute Cardiovasc Care. 2026 Aug 29;15(8):622-626. doi: 10.1093/ehjacc/zuag027.
PubMed 41761704
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04694092
- Acronym / sponsor ID
- LARISA / LARISA2020
- Conditions
- Atrial Fibrillation, Atrial Fibrillation Rapid, Acute Heart Failure, Left Ventricular Dysfunction
- Keywords
- rate control, betablockers, landiolol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to intensive rate control with landiolol vs. standard therapy
| Arm | Type | Receives |
|---|---|---|
| Intensive rate control with landiolol | Experimental | Drug: Intensive heart rate control with landiololIntensive heart rate control using landiolol with the goal to achieve HR<115 during the first 2 hours. |
| Standard therapy | Active comparator | Drug: Standard approach to heart rate controlStandard heart rate control with therapy other than landiolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive heart rate control with landiololAlso: Rapibloc, Amomed Pharma, AustriaIntensive heart rate control preferably with the use of short-acting betablocker landiolol in combination with digoxin | Drug | Intensive rate control with landiolol |
| Standard approach to heart rate controlStandard heart rate control with intravenous or oral beta-blockers and/or antiarrhythmic in combination with digoxin | Drug | Standard therapy |
Primary outcome
Heart rate control
Time frame: during the first 2 hours
Achievement of heart rate <115/min for at least 15 mins
Change in patient-reported symptoms
Time frame: at 2 hours
Change of patient-reported dyspnea evaluated 1-10 visual analog scale (1=unbearable dyspnea, 10=no symptoms)
5 secondary outcomes
Significant change of heart rate
Time frame: During the first 2 hours
Heart rate and heart rhythm
Time frame: heart rate measured at hours 2, 12 and 48 of the study protocol
Safety - hypotension
Time frame: first 2 hours
Change in cardiac index
Time frame: evaluated between baseline and hour 2
Change in stroke volume index
Time frame: evaluated between baseline and hour 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Derived from this study: PubMed 41761704Sramko M, Benak A, Toman J, Kleissner M, Pazdernik M, Kautzner J. Landiolol for rate control in decompensated heart failure due to atrial fibrillation: the LARISA trial. Eur Heart J Acute Cardiovasc Care. 2026 Aug 29;15(8):622-626. doi: 10.1093/ehjacc/zuag027.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Atrial Fibrillation and Atrial Fibrillation Rapid, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Sramko, MD., PhD. (+420776246127, marek.sramko@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate control (time frame: during the first 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.