1. Oral levosimendan in patients with severe chronic heart failure --the PERSIST study
- Author
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Toni Sarapohja, Matti Kivikko, John G.F. Cleland, Jaan Eha, Markku S. Nieminen, Pentti Põder, and Yuri N. Belenkov
- Subjects
Male ,medicine.medical_specialty ,Cardiotonic Agents ,Psychometrics ,Placebo ,Severity of Illness Index ,law.invention ,Randomized controlled trial ,Quality of life ,Double-Blind Method ,law ,Oral administration ,Internal medicine ,Surveys and Questionnaires ,Severity of illness ,Natriuretic Peptide, Brain ,Medicine ,Humans ,Simendan ,Aged ,Heart Failure ,business.industry ,Hydrazones ,Levosimendan ,Middle Aged ,medicine.disease ,Peptide Fragments ,Clinical trial ,Pyridazines ,Heart failure ,Chronic Disease ,Cardiology ,Disease Progression ,Quality of Life ,Female ,Cardiology and Cardiovascular Medicine ,business ,Biomarkers ,medicine.drug - 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 (pb0.001) which was accompanied by a substantial and persistent reduction in NT-proBNP (−30–40%) (pb0.001). 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. © 2008 European Society of Cardiology. Published by Elsevier B.V. All rights reserved.
- Published
- 2008