Evidence map›Paper›PMID 41711226›Full record

Trial reportESC heart failure2026

The possible impact of levosimendan infusions on clinical course of heart failure: the results of the LEIA-HF study.

Ewelina Kazimierczyk, Remigiusz Kazimierczyk, Anna M Imiela, Dominika Południewska, Ewelina Rogalska, Anna Szyszkowska, Klaudia Mickiewicz, Franciszek Kukliński, Teresa Fernandez-Moreno, Marek Gierlotka and 12 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase IV
In one paragraph

Trial report in ESC heart failure, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

22 authors.

Ewelina KazimierczykDepartment of Cardiology and Internal Medicine with Cardiac Intensive Care Unit, Medical University of Bialystok, Bialystok, Poland.
Remigiusz KazimierczykDepartment of Cardiology and Internal Medicine with Cardiac Intensive Care Unit, Medical University of Bialystok, Bialystok, Poland.ORCID 0000-0003-4517-1498
Anna M ImielaDepartment of Internal Disease and Cardiology, Center for Management of Venous Thromboembolic Disease, Medical University of Warsaw, Warsaw, Poland.
Dominika PołudniewskaDepartment of Cardiology and Internal Medicine with Cardiac Intensive Care Unit, Medical University of Bialystok, Bialystok, Poland.
Ewelina RogalskaDepartment of Cardiology and Internal Medicine with Cardiac Intensive Care Unit, Medical University of Bialystok, Bialystok, Poland.
Anna SzyszkowskaDepartment of Cardiology and Internal Medicine with Cardiac Intensive Care Unit, Medical University of Bialystok, Bialystok, Poland.
Klaudia MickiewiczDepartment of Cardiology and Internal Medicine with Cardiac Intensive Care Unit, Medical University of Bialystok, Bialystok, Poland.
Franciszek KuklińskiDepartment of Intensive Cardiac Care, Medical University of Bialystok, Bialystok, Poland.
Teresa Fernandez-MorenoDepartment of Intensive Cardiac Care, Medical University of Bialystok, Bialystok, Poland.
Marek GierlotkaDepartment of Cardiology, Institute of Medical Sciences, University of Opole, Opole, Poland.
Ewa Straburzyńska-MigajFirst Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.ORCID 0000-0002-0545-3370
Jadwiga M NesslerDepartment of Coronary Disease and Heart Failure, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Agnieszka PawlakDepartment of Cardiology, National Medical Institute of the Ministry of Interior and Administration, Warszawa, Poland.
Mariusz Gąsior3rd Department of Cardiology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.
Jacek KubicaDepartment of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Bydgoszcz, Poland.
Miłosz JaguszewskiFirst Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.
Jarosław D KasprzakFirst Department of Cardiology, Medical University of Lodz, Lodz, Poland.
Agata Bielecka-DąbrowaDepartment of Cardiology and Adult Congenital Diseases, Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland.
Wojciech WojakowskiDivision of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.ORCID 0000-0002-3681-5207
Przemysław LeszekDepartment of Heart Failure and Transplantology, National Institute of Cardiology, Warsaw, Poland.
Łukasz SzarpakInstitute of Medical Sciences, The John Paul II Catholic University of Lublin, Lublin, Poland.
Agnieszka TycińskaDepartment of Cardiology and Internal Medicine with Cardiac Intensive Care Unit, Medical University of Bialystok, Bialystok, Poland.ORCID 0000-0001-7855-7261

Funding

Polish Research Agency 2019/ABM/01/00017
6 · The paper itself

Abstract

introductionIntermittent administration of levosimendan has recently been introduced for long-term use in patients with advanced heart failure (HF). However, the impact of this therapy on survival remains inconclusive.

methodsLevosimendan in ambulatory HF patients was a multicentre, randomized, double-blind, placebo-controlled, Phase IV clinical trial of intermittent levosimendan administration in patients with ambulatory stable advanced HF [left ventricular ejection fraction ≤35%, New York Heart Association Classes III and IV]. The primary clinical endpoint of the study was composed of death from any cause or unplanned hospitalization for HF, whichever occurred first in a 12-month follow-up period. Infusion started at a dose of 0.05 μg/kg/min and lasted ∼24 h (up to a maximum dose of 12.5 mg) every 4 weeks. The study was conducted in nine centres around Poland. The study was prematurely terminated due to excess of deaths in the active treatment group. Finally, 64 (out of 350 planned) patients were recruited to the study.

resultsSixty-four patients with advanced HF [age-64.2 ± 13.1 years, 57 (89%) men] were enrolled into the study. At baseline visit 34 (53%) patients were randomly assigned to the levosimendan group (study group) and 30 (47%) to the placebo group. Study drug administration resulted in a significant decrease in N-terminal pro-B-type natriuretic peptide concentrations [5084 pg/ml (306-23.203) vs 2027 pg/ml (872-2174), P = .02) and left ventricular ejection fraction improvement (20.9 ± 5.9% vs 29.27 ± 5.23%, P = .015) in the study group. These patients also had clinical endpoint numerically more often than patients in the placebo group [22 (64.71%) vs 14 (46.67%); P = .14], including significantly higher deaths [7 (100%) vs 0, P = .02].

conclusionsIn a selected group of stable ambulatory advanced HF (left ventricular ejection fraction ≤35%, New York Heart Association Classes III and IV) patients, repetitive levosimendan 24 h infusion might be an additional therapeutic option but observed deaths may raise its safety issue.

Indexed as

Heart FailureHydrazonesPyridazinesSimendanStroke VolumeVentricular Function, LeftAgedCardiotonic AgentsDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansInfusions, IntravenousMaleMiddle AgedCardiotonic AgentsHydrazonesPyridazinesSimendanCongestionHeart failureInotropesLevosimendan

Identifiers

PMID41711226
PMCPMC13108320

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.