Medical Support and Surgery of the Failing Heart: Levosimendan

Toller, Wolfgang; Knez, Igor

doi:10.1177/145749690709600206

Cited by 2 publications

(1 citation statement)

References 18 publications

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“…Previous studies have indicated reverse remodelling of the left ventricle after repeated infusions of levosimendan 15. In addition, experimental and clinical findings suggest an anti‐stunning effect of levosimendan 20. Hence, the aim of the MRI substudy is to investigate whether serial infusions of levosimendan in severe heart failure patients can cause reverse remodelling of the left ventricle and recruitment of hibernating myocardium in ischaemic cardiomyopathy.…”

Section: Methodsmentioning

confidence: 99%

Rationale and design of the multicentre randomized trial investigating the efficacy and safety of pulsed infusions of levosimendan in outpatients with advanced heart failure (LevoRep study)

Altenberger

Parissis

Ulmer

et al. 2010

European J of Heart Fail

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AimsAdvanced chronic heart failure (CHF) is a clinical syndrome with high morbidity and mortality that often requires inotropic support for the alleviation of symptoms and congestion. There are no definite evidence-based data on the safety and efficacy of intermittent infusions of inotropic agents in this severe clinical condition. The purpose of the LevoRep study is to clarify whether pulsed infusions of the new inotropic agent levosimendan administered in an outpatient setting can safely improve exercise capacity, quality-of -life (QoL), and outcome in advanced CHF patients. MethodsThe LevoRep study is a prospective, randomized, double-blind, placebo-controlled, two-armed, parallel-group, multicentre trial. The study is designed to investigate the effects of pulsed infusions of levosimendan (6 h administration at 0.2 mg/kg/min every 2 weeks) on the composite endpoint (primary endpoint) comprising changes in functional capacity and QoL (20% or greater improvement in the 6 min walk test and 15% or higher score on the Kansas City Cardiomyopathy Questionnaire) at the end of the 24 week study period. In addition, short-term (8 weeks from randomization) and long-term (24 weeks from randomization) event-free survival (secondary endpoint) will be assessed. The LevoRep study aims to include 120 outpatients with advanced CHF. ConclusionLevoRep is the first prospective randomized trial to assess the effects of pulsed infusions of an inotrope on hard endpoints as well as on the safety in patients with advanced CHF on an outpatient basis. The results are expected to promote the development of evidence-based recommendations for the ambulatory management of patients with end-stage heart failure.--

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Section: Methodsmentioning

confidence: 99%

Rationale and design of the multicentre randomized trial investigating the efficacy and safety of pulsed infusions of levosimendan in outpatients with advanced heart failure (LevoRep study)

Altenberger

Parissis

Ulmer

et al. 2010

European J of Heart Fail

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Levosimendan versus placebo in cardiac surgery: a systematic review and meta-analysis

Tena

Urso

González

et al. 2018

Interactive CardioVascular and Thoracic Surgery

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The aim of this meta-analysis was to review all published randomized clinical trials comparing levosimendan versus placebo in patients undergoing cardiac surgery. PubMed, EMBASE and the Cochrane library database of clinical trials were searched for prospective randomized clinical trials investigating the perioperative use of levosimendan versus placebo in patients undergoing adult cardiac surgery from 1 May 2000 to 10 April 2017. Binary outcomes from individual studies were analysed to compute individual and pooled risk ratios (RRs) with pertinent 95% confidence intervals (CIs). Fourteen randomized clinical trials with a total of 2243 patients were included in this review. Overall meta-analysis results demonstrated that levosimendan was associated with a significant reduction in 30-day mortality (RR = 0.71, 95% CI = 0.53-0.95; P = 0.023). Subgroup analysis showed that this benefit was confined to the moderate and low ejection fraction studies (RR = 0.44, 95% CI = 0.27-0.70; P < 0.001), whereas no benefit was observed in the preserved ejection fraction studies (RR = 1.06, 95% CI = 0.72-1.56; P = 0.78). Levosimendan also reduced the risk of renal replacement therapy (RR = 0.66, 95% CI = 0.47-0.92; P = 0.015) and low cardiac output (RR = 0.40, 95% CI = 0.22-0.73; P = 0.003). No significant differences were detected, between the levosimendan group and the placebo group, in terms of risk of myocardial injury (RR = 0.90, 95% CI = 0.69-1.17; P = 0.44), intensive care unit stay (weighted mean differences = -0.57, 95% CI = -1.15 to 0.01; P = 0.055) and the use of ventricular assist device (RR = 0.42, 95% CI = 0.07-2.63; P = 0.35). In conclusion, levosimendan was associated with a reduced risk of mortality, renal replacement therapy and low cardiac output syndrome in patients undergoing cardiac surgery.

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Medical Support and Surgery of the Failing Heart: Levosimendan

Cited by 2 publications

References 18 publications

Rationale and design of the multicentre randomized trial investigating the efficacy and safety of pulsed infusions of levosimendan in outpatients with advanced heart failure (LevoRep study)

Rationale and design of the multicentre randomized trial investigating the efficacy and safety of pulsed infusions of levosimendan in outpatients with advanced heart failure (LevoRep study)

Levosimendan versus placebo in cardiac surgery: a systematic review and meta-analysis

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