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European Journal of Heart Failure 2008 10(12):1246-1254; doi:10.1016/j.ejheart.2008.09.006
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© 2008 European Society of Cardiology

Oral levosimendan in patients with severe chronic heart failure—The PERSIST study

Markku S. Nieminena,*, John G.F. Clelandb, Jaan Ehac, Yuri Belenkovd, Matti Kivikkoe, Pentti Põdere and Toni Sarapohjae

a Division of Cardiology, Helsinki University Central Hospital Helsinki, Finland
b Cardio-Vascular-Respiratory Division: Cardiology, The University of Hull United Kingdom
c Clinic of Cardiology, Tartu University Tartu, Estonia
d The A.L. Myasnikov Institute of Clinical Cardiology, Cardiology Research Center Moscow, Russia
e Cardiology Unit, Clinical Research and Development Orion Pharma, Espoo, Finland

* Corresponding author. Division of Cardiology, Helsinki University Central Hospital, Helsinki, Finland, Stenbäckinkatu 9, P.O. Box 100, 00290 Helsinki, Finland. Tel.: +358 9 4711; fax: +358 9 4715401. E-mail address: markku.nieminen{at}hus.fi (M.S. Nieminen).


  Abstract

Background: Intravenous levosimendan improves symptoms in acutely decompensated heart failure.

Aims: To evaluate the effects of oral levosimendan in severe chronic heart failure (CHF).

Methods: 307 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.

Results: Patients 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).

Conclusion: Levosimendan 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.

Key Words: Levosimendan • Heart failure • Oral administration • NT-proBNP • Quality of life

Received March 10, 2008; Revised July 14, 2008; Accepted September 10, 2008


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