Evidence map›Paper›PMID 39947241›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2025

Landiolol is effective and safe in paediatric supraventricular tachycardia: evidence from a European prospective multicentre open-label phase III study (LANDI-PED).

Ina Michel-Behnke, Matthias Müller, Brigitte Stiller, Thomas Kriebel, Majed Kanaan, László Környei, Matthias Mai, Roman Gebauer, Jens Meier, Ferran Roses-Noguer and 7 more

Abstract readMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Ina Michel-BehnkeDepartment of Paediatrics and Adolescent Medicine, Division of Paediatric Cardiology, Medical University of Vienna, General Hospital Vienna, Vienna, Austria.ORCID 0000-0002-3131-573X
Matthias MüllerDepartment of Anaesthesiology and Intensive Care Medicine, Paediatric Heart Centre Giessen, University Hospital Giessen and Marburg GmbH, Giessen, Germany.ORCID 0000-0001-6546-9860
Brigitte StillerDepartment of Congenital Heart Disease and Paediatric Cardiology, Faculty of Medicine, Heart Centre Freiburg University, University of Freiburg, Freiburg, Germany.ORCID 0000-0002-7657-4647
Thomas KriebelDepartment of Paediatrics and Paediatric Cardiology, Westpfalz Hospital, Kaiserslautern, Germany.ORCID 0000-0003-3907-8350
Majed KanaanDepartment of Paediatric Cardiology, Children's Heart Centre Aachen, University Hospital RWTH Aachen, Aachen, Germany.ORCID 0000-0003-1366-0748
László KörnyeiGottsegen National Cardiovascular Centre, Paediatric Heart Centre, Budapest, Hungary.ORCID 0000-0001-7012-6133
Matthias MaiPaediatrics 3-Centre for Congenital Heart Defects Stuttgart, Paediatric Intensive Care, Pulmonology and Allergology, Stuttgart Hospital-Olgahospital, Stuttgart, Germany.
Roman GebauerClinic for Paediatric Cardiology, Heart Centre Leipzig GmbH, Leipzig, Germany.ORCID 0009-0000-9803-5532
Jens MeierDepartment of Anaesthesia and Intensive Care, Kepler University Clinic, Kepler University, Linz, Austria.ORCID 0000-0002-8727-2257
Ferran Roses-NoguerPaediatric Cardiology Department, University Hospital Vall d' Hebron, Barcelona, Spain.ORCID 0000-0002-5955-7490
Martin UngerAOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria.ORCID 0000-0002-9600-8618
Stefanie SchlagerAOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria.ORCID 0009-0005-7755-5981
Charu CharuAOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria.ORCID 0000-0001-9069-5173
Christoph KladeAOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria.
Kurt KrejcyAOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria.
Jakob AckerlAOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria.
Günther KrumplBoard of Directors, AOP Health International Management AG, Ruggell, Liechtenstein.

Funding

AOP Orphan Pharmaceuticals GmbH
6 · The paper itself

Abstract

aimsLandiolol, an ultra-fast acting super-selective beta-blocker, was investigated for the first time in Europe in a prospective clinical study for the management of supraventricular tachycardia (SVT) among paediatric patients. METHODS AND

resultsThe LANDI-PED study was a prospective, multicentre, open-label, uncontrolled phase III study aiming to investigate the efficacy, safety, and pharmacokinetics (PK) of landiolol in paediatric patients. Sixty patients in surgical and non-surgical settings aged ≥1 day to <18 years with SVTs of various aetiologies received landiolol as a continuous intravenous infusion starting with 5 μg/kg/min titrated up to 40 μg/kg/min depending on heart rate (HR) reduction for up to a maximum of 24 h. The primary endpoint was restoration of normal sinus rhythm (NSR) within 210 min of infusion start. The primary endpoint was achieved in 15 (25.0%) patients. A total of 24 (40.0%) patients achieved a HR reduction of at least 20% within 210 min of landiolol infusion. A significant HR reduction was observed within minutes post-infusion, with a mean (±SD) reduction after 210 min of -13.2 (±11.5)% (P < 0.0001) in the overall population. By infusion end, 51.7% of patients achieved HR reduction of at least 20% from baseline and/or NSR conversion. The PK characteristics were consistent with the known profile of landiolol among adults. The most common adverse drug reaction was hypotension (10%).

conclusionLandiolol is effective and safe in the treatment of SVTs in the paediatric population as demonstrated by reduction of HR and/or restoring NSR. Landiolol was well tolerated with no novel safety concerns reported. CLINICAL

trial registrationEU Clinical Trial Register; EudraCT Number: 2015-001129-17.

Indexed as

Adrenergic beta-AntagonistsAnti-Arrhythmia AgentsHeart RateMorpholinesTachycardia, SupraventricularUreaAdolescentAge FactorsChildChild, PreschoolEuropeFemaleHumansInfantInfant, NewbornInfusions, IntravenousAdrenergic beta-AntagonistsAnti-Arrhythmia AgentslandiololMorpholinesUreaHeart rateLandiololPaediatricsSinus rhythmSupraventricular tachycardiaUltra-fast acting super-selective beta-blocker

Identifiers

PMID39947241
PMCPMC11879349

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.