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; Hanno Ulmer; Bojan Vrtovec; Gerhard Wikström; Johann Altenberger

doi:10.1002/ehf2.12366

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, Hanno Ulmer, Bojan Vrtovec, Gerhard Wikström, Johann Altenberger

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

12 Citationer (Scopus)

46 Downloads (Pure)

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.

Originalsprog	Engelsk
Tidsskrift	ESC heart failure
Vol/bind	6
Udgave nummer	1
Sider (fra-til)	174-181
Antal sider	8
ISSN	2055-5822
DOI	https://doi.org/10.1002/ehf2.12366
Status	Udgivet - feb. 2019

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10.1002/ehf2.12366Licens: CC BY-NC-ND

Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post‐discharge periodForlagets udgivne version, 314 KBLicens: CC BY-NC-ND

Citationsformater

Pölzl, G., Allipour Birgani, S., Comín-Colet, J., Delgado, J. F., Fedele, F., García-Gonzáles, M. J., Gustafsson, F., Masip, J., Papp, Z., Störk, S., Ulmer, H., Vrtovec, B., Wikström, G., & Altenberger, J. (2019). Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period. ESC heart failure, 6(1), 174-181. https://doi.org/10.1002/ehf2.12366

Pölzl, G, Allipour Birgani, S, Comín-Colet, J, Delgado, JF, Fedele, F, García-Gonzáles, MJ, Gustafsson, F, Masip, J, Papp, Z, Störk, S, Ulmer, H, Vrtovec, B, Wikström, G & Altenberger, J 2019, 'Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period', ESC heart failure, bind 6, nr. 1, s. 174-181. https://doi.org/10.1002/ehf2.12366

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title = "Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period",

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.",

keywords = "Advanced heart failure, Global rank endpoint, Hospitalization, Levosimendan, N-terminal pro-brain natriuretic peptide, Randomized controlled trial",

author = "Gerhard P{\"o}lzl and {Allipour Birgani}, Shadab and Josep Com{\'i}n-Colet and Delgado, {Juan F.} and Francesco Fedele and Garc{\'i}a-Gonz{\'a}les, {Mart{\'i}n Jes{\'u}s} and Finn Gustafsson and Josep Masip and Zolt{\'a}n Papp and Stefan St{\"o}rk and Hanno Ulmer and Bojan Vrtovec and Gerhard Wikstr{\"o}m and Johann Altenberger",

year = "2019",

month = feb,

doi = "10.1002/ehf2.12366",

language = "English",

volume = "6",

pages = "174--181",

journal = "E S C Heart Failure",

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T1 - Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period

AU - Pölzl, Gerhard

AU - Allipour Birgani, Shadab

AU - Comín-Colet, Josep

AU - Delgado, Juan F.

AU - Fedele, Francesco

AU - García-Gonzáles, Martín Jesús

AU - Gustafsson, Finn

AU - Masip, Josep

AU - Papp, Zoltán

AU - Störk, Stefan

AU - Ulmer, Hanno

AU - Vrtovec, Bojan

AU - Wikström, Gerhard

AU - Altenberger, Johann

PY - 2019/2

Y1 - 2019/2

N2 - 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.

AB - 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.

KW - Advanced heart failure

KW - Global rank endpoint

KW - Hospitalization

KW - Levosimendan

KW - N-terminal pro-brain natriuretic peptide

KW - Randomized controlled trial

U2 - 10.1002/ehf2.12366

DO - 10.1002/ehf2.12366

M3 - Journal article

C2 - 30378288

AN - SCOPUS:85055920495

SN - 2055-5822

VL - 6

SP - 174

EP - 181

JO - E S C Heart Failure

JF - E S C Heart Failure

IS - 1

ER -

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

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