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Eur. J. Heart Fail. · Dec 2008
Randomized Controlled Trial Multicenter Study Clinical TrialOral levosimendan in patients with severe chronic heart failure --the PERSIST study.
- Markku S Nieminen, John G F Cleland, Jaan Eha, Yuri Belenkov, Matti Kivikko, Pentti Põder, and Toni Sarapohja.
- Division of Cardiology, Helsinki University Central Hospital, Helsinki, Finland. markku.nieminen@hus.fi
- Eur. J. Heart Fail. 2008 Dec 1;10(12):1246-54.
BackgroundIntravenous levosimendan improves symptoms in acutely decompensated heart failure.AimsTo evaluate the effects of oral levosimendan in severe chronic heart failure (CHF).Methods307 patients with NYHA IIIB-IV CHF were randomly assigned, double-blind, to levosimendan 1 mg once or twice daily or placebo for at least 180 days. An exploratory primary end-point, the Patient Journey, a composite consisting of repeated symptom assessments, worsening heart failure and mortality during 60 days was used. Minnesota Living with Heart Failure quality of life score (MLHFQoL) and NT-proBNP were assessed repeatedly.ResultsPatients assigned to a lower dose of levosimendan had more severe CHF at baseline. No differences in symptoms emerged and worsening heart failure events and death were similar resulting in a similar Patient Journey score with levosimendan and placebo (p=0.567). Compared to placebo, a net improvement of 3-4 points in MLHFQoL at several time-points in favour of the combined levosimendan groups was observed (p<0.001) which was accompanied by a substantial and persistent reduction in NT-proBNP (-30-40%) (p<0.001).ConclusionLevosimendan improved QoL and decreased NT-proBNP but did not improve the Patient Journey composite in patients with severe CHF. Further research with this compound is warranted to clarify safety and efficacy.
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