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Repetitive levosime...
Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period : The multinational randomized LeoDOR trial
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- Poelzl, Gerhard (författare)
- Med Univ Innsbruck, Dept Internal Med 3, A-6020 Innsbruck, Austria.;Med Univ Innsbruck, Dept Internal Med 3, Anichstr 35, A-6020 Innsbruck, Austria.
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- Altenberger, Johann (författare)
- Paracelsus Med Private Univ, Teaching Hosp, Cardiac Rehabil Ctr Grossgmain, Pensionsversicherungsanstalt, Salzburg, Austria.
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- Comin-Colet, Josep (författare)
- Bellvitge Univ Hosp, Dept Cardiol, Barcelona, Spain.;Univ Barcelona Hospitalet Llobregat, IDIBELL, CIBER CV, Barcelona, Spain.
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- Delgado, Juan F. (författare)
- Univ Hosp 12 Octubre, Dept Cardiol, CIBERCV, Madrid, Spain.
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- Fedele, Francesco (författare)
- Sapienza Univ Rome, Dept Cardiovasc Resp Nephrol Anesthesiol & Geriat, Rome, Italy.
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- Garcia-Gonzalez, Martin Jesus (författare)
- Univ Hosp Canarias, Anaesthesiol Dept, Santa Cruz De Tenerife, Spain.
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- Gustafsson, Finn (författare)
- Copenhagen Univ Hosp, Dept Cardiol, Copenhagen, Denmark.
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- Masip, Josep (författare)
- Univ Barcelona, Consorci Sanit Integral, Res Direct, Barcelona, Spain.
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- Papp, Zoltan (författare)
- Univ Debrecen, Fac Med, Dept Cardiol, Div Clin Physiol, Debrecen, Hungary.
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- Stoerk, Stefan (författare)
- Univ Hosp Wurzburg, Comprehens Heart Failure Ctr, D-97080 Wurzburg, Germany.;Univ Hosp Wurzburg, Dept Internal Med 1, Wurzburg, Germany.
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- Ulmer, Hanno (författare)
- Med Univ Innsbruck, Inst Med Stat & Informat, Innsbruck, Austria.
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- Maier, Sarah (författare)
- Med Univ Innsbruck, Inst Med Stat & Informat, Innsbruck, Austria.
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- Vrtovec, Bojan (författare)
- Univ Med Ctr Ljubljana, Dept Cardiol, Ljubljana, Slovenia.
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- Wikström, Gerhard (författare)
- Uppsala universitet,Kardiologi
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- Zima, Endre (författare)
- Semmelweis Univ, Heart & Vasc Ctr, Cardiac Intens Care Unit, Budapest, Hungary.
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- Bauer, Axel (författare)
- Med Univ Innsbruck, Dept Internal Med 3, A-6020 Innsbruck, Austria.
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Med Univ Innsbruck, Dept Internal Med 3, A-6020 Innsbruck, Austria;Med Univ Innsbruck, Dept Internal Med 3, Anichstr 35, A-6020 Innsbruck, Austria. Paracelsus Med Private Univ, Teaching Hosp, Cardiac Rehabil Ctr Grossgmain, Pensionsversicherungsanstalt, Salzburg, Austria. (creator_code:org_t)
- John Wiley & Sons, 2023
- 2023
- Engelska.
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Ingår i: European Journal of Heart Failure. - : John Wiley & Sons. - 1388-9842 .- 1879-0844. ; 25:11, s. 2007-2017
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Aim The LeoDOR trial explored the efficacy and safety of intermittent levosimendan therapy in the vulnerable phase following a hospitalization for acute heart failure (HF) Methods and results In this prospective multicentre, double-blind, two-armed trial, patients with advanced HF were randomized 2:1 at the end of an index hospitalization for acute HF to intermittent levosimendan therapy or matching placebo for 12weeks. All patients had left ventricular ejection fraction (LVEF) =30% during index hospitalization. Levosimendan was administered according to centre preference either as 6 h infusion at a rate of 0.2 mu g/kg/min every 2weeks, or as 24 h infusion at a rate of 0.1 mu g/kg/min every 3weeks. The primary efficacy assessment after 14weeks was based on a global rank score consisting of three hierarchical groups. Secondary clinical endpoints included the composite risk of tiers 1 and 2 at 14 and 26weeks, respectively. Due to the COVID-19 pandemic, the planned number of patients could not be recruited. The final modified intention-to-treat analysis included 145 patients (93 in the combined levosimendan arm, 52 in the placebo arm), which reduced the statistical power to detect a 20% risk reduction in the primary endpoint to 60%. Compared with placebo, intermittent levosimendan had no significant effect on the primary endpoint: the mean rank score was 72.55 for the levosimendan group versus 73.81 for the placebo group (p= 0.863). However, there was a signal towards a higher incidence of the individual clinical components of the primary endpoint in the levosimendan group versus the placebo group both after 14weeks (hazard ratio [HR] 2.94, 95% confidence interval [CI] 1.12- 7.68; p= 0.021) and 26weeks (HR 1.64, 95% CI 0.87- 3.11; p= 0.122). Among patients recently hospitalized with HF and reduced LVEF, intermittent levosimendan therapy did not improve post-hospitalization clinical stability. [GRAPHICS.]
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- Levosimendan
- Acute heart failure
- Randomised controlled trial
- Hospitalization
- N-terminal pro-B-type natriuretic peptide
- Global rank endpoint
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- ref (ämneskategori)
- art (ämneskategori)
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Poelzl, Gerhard
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Altenberger, Joh ...
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Comin-Colet, Jos ...
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Delgado, Juan F.
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Fedele, Francesc ...
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Garcia-Gonzalez, ...
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visa fler...
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Gustafsson, Finn
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Masip, Josep
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Papp, Zoltan
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Stoerk, Stefan
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Ulmer, Hanno
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Maier, Sarah
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Vrtovec, Bojan
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Wikström, Gerhar ...
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Zima, Endre
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Bauer, Axel
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visa färre...
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