Evidence map›Paper›PMID 30378288›Full record

Trial reportESC heart failure2019

Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period.

Gerhard Pölzl, Shadab Allipour Birgani, Josep Comín-Colet, Juan F Delgado, Francesco Fedele, Martín Jesús García-Gonzáles, Finn Gustafsson, Josep Masip, Zoltán Papp, Stefan Störk and 4 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in ESC heart failure, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 4% of its field
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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.

  1. Pooled it
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  5. Efficacy of levosimendan infusion in patients undergoing a left ventricular assist device implant in a propensity score matched analysis of the EUROMACS registry-the Euro LEVO-LVAD study.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2023
    Article
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  7. Review
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  10. Review
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  15. Levosimendan Efficacy and Safety: 20 Years of SIMDAX in Clinical Use.Journal of cardiovascular pharmacology · 2020
    Review
  16. Review
  17. Facing up to the challenges of acute heart failure.European heart journal supplements : journal of the European Society of Cardiology · 2020
    Article
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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

14 authors at 12 institutions in 9 countries.

Gerhard PölzlDepartment of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.
Shadab Allipour BirganiDepartment of Internal Medicine III, Medical University Innsbruck, Innsbruck, Austria.
Josep Comín-ColetDepartment of Cardiology, Bellvitge University Hospital and IDIBELL, University of Barcelona Hospitalet de Llobregat, Barcelona, Spain.
Juan F DelgadoDepartment of Cardiology, University Hospital 12 de Octubre, CIBERCV, Madrid, Spain.
Francesco FedeleDepartment of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Martín Jesús García-GonzálesDepartment of Cardiology, University Hospital Canarias, San Cristóbal de La Laguna, Tenerife, Spain.
Finn GustafssonDepartment of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Josep MasipIntensive Care Department, Consorci Sanitari Integral, University of Barcelona, Barcelona, Spain.
Zoltán PappDepartment of Cardiology, Division of Clinical Physiology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.
Stefan StörkDepartment of Internal Medicine and Comprehensive Heart Failure Center, University Hospital Würzburg, Würzburg, Germany.
Hanno UlmerDepartment for Medical Statistics, Informatics and Health Economics, Medical University Innsbruck, Innsbruck, Austria.
Bojan VrtovecDepartment of Cardiology, University Medical Center Ljubljana, Ljubljana, Slovenia.
Gerhard WikströmDepartment of Cardiology, Institute of Medical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Johann AltenbergerCardiac Rehabilitation Center Grossgmain, Pensionsversicherungsanstalt, Teaching Hospital of Paracelsus Medical Private University, Salzburg, Austria.
Innsbruck Medical University · ATBellvitge University Hospital · ESCentro de Investigación en Red en Enfermedades Cardiovasculares · ESCopenhagen University Hospital · DKLjubljana University Medical Centre · SIParacelsus Medical University · ATSapienza University of Rome · ITUniversidad de La Laguna · ESUniversitat de Barcelona · ESUniversitätsklinikum Würzburg · DEUniversity of Debrecen · HUUppsala University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hospitalization for acute heart failure (HF) is associated with a substantial morbidity burden and with associated healthcare costs and an increased mortality risk. However, few if any major medical innovations have been witnessed in this area in recent times. Levosimendan is a first-in-class calcium sensitizer and potassium channel opener indicated for the management of acute HF. Experience in several clinical studies has indicated that administration of intravenous levosimendan in intermittent cycles may reduce hospitalization and mortality rates in patients with advanced HF; however, none of those trials were designed or powered to give conclusive insights into that possibility. This paper describes the rationale and protocol of LeoDOR (levosimendan infusions for patients with advanced chronic heart failure), a randomized, double-blind, placebo-controlled, international, multicentre trial that will explore the efficacy and safety of intermittent levosimendan therapy, in addition to optimized standard therapy, in patients following hospitalization for acute HF. Salient features of LeoDOR include the use of two treatment regimens, in order to evaluate the effects of different schedules and doses of levosimendan during a 12 week treatment phase, and the use of a global rank primary endpoint, in which all patients are ranked across three hierarchical groups ranging from time to death or urgent heart transplantation or implantation of a ventricular assist device to time to rehospitalization and, lastly, time-averaged proportional change in N-terminal pro-brain natriuretic peptide. Secondary endpoints include changes in HF symptoms and functional status at 14 weeks.

Indexed as

Patient DischargeCardiotonic AgentsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFollow-Up StudiesHeart FailureHumansInfusions, IntravenousSimendanStroke VolumeTreatment OutcomeCardiotonic AgentsSimendanAdvanced heart failureGlobal rank endpointHospitalizationLevosimendanN-terminal pro-brain natriuretic peptideRandomized controlled trial

Identifiers

PMID30378288
PMCPMC6351894
OpenAlexW2899502385

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.