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)

European Journal of Heart Failure

Volumn 12, Issue 2, 2010, Pages 186-192

  Altenberger, Johann ^a   Parissis, John T ^b   Ulmer, Hanno ^c   Poelzl, Gerhard ^c  

^a PARACELSUS MEDICAL UNIVERSITY   (Austria)

^b UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^c INNSBRUCK MEDICAL UNIVERSITY   (Austria)

Author keywords

Efficacy; Heart failure; Inotropes; Management; Prognosis; Quality of life; Safety

Indexed keywords

LEVOSIMENDAN;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EVENT FREE SURVIVAL; EXERCISE; EXERCISE TEST; FUNCTIONAL STATUS; HEART FAILURE; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OUTCOME ASSESSMENT; OUTPATIENT; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

CARDIOTONIC AGENTS; DOUBLE-BLIND METHOD; FEMALE; HEALTH STATUS INDICATORS; HEART FAILURE; HUMANS; HYDRAZONES; KAPLAN-MEIER ESTIMATE; MALE; OUTPATIENTS; PULSATILE FLOW; PYRIDAZINES; QUALITY OF LIFE; QUESTIONNAIRES; RESEARCH DESIGN;

EID: 75149183611     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1093/eurjhf/hfp189     Document Type: Article

References (34)

1. Jessup M, Brozena S. Heart failure. N Engl J Med 2003;348:2007-2018.
2. Metra M, Ponikowski P, Dickstein K, McMurray JJ, Gavazzi A, Bergh CH, Fraser AG, Jaarsma T, Pitsis A, Mohacsi P, Bohm M, Anker S, Dargie H, Brutsaert D, Komajda M. Advanced chronic heart failure: a position statement from the study group on advanced heart failure of the heart failure association of the European society of cardiology. Eur J Heart Fail 2007;9:684-694.
3. Jaarsma T, Beattie JM, Ryder M, Rutten FH, McDonagh T, Mohacsi P, Murray SA, Grodzicki T, Bergh I, Metra M, Ekman I, Angermann C, Leventhal M, Pitsis A, Anker SD, Gavazzi A, Ponikowski P, Dickstein K, Delacretaz E, Blue L, Strasser F, McMurray J. Palliative care in heart failure: a position statement from the palliative care workshop of the heart failure association of the European society of cardiology. Eur J Heart Fail 2009;11:433-443.
4. Young JB, Moen EK. Outpatient parenteral inotropic therapy for advanced heart failure. J Heart Lung Transplant 2000;19(Suppl.):S49-S57.
5. Rapezzi C, Bracchetti G, Branzi A, Magnani B. The case against outpatient parent-eral inotropic therapy for advanced heart failure. J Heart Lung Transplant 2000; 19(Suppl.):S58-S63.
6. Archan S, Toller W. Levosimendan: current status and future prospects. Curr Opin Anaesthesiol 2008;21:78-84.
7. Pollesello P, Ovaska M, Kaivola J, Tilgmann C, Lundstrom K, Kalkkinen N, Ulmanen I, Nissinen E, Taskinen J. Binding of a new Ca2+ sensitizer, levosimen-dan, to recombinant human cardiac troponin C. A molecular modelling, fluorescence probe, and proton nuclear magnetic resonance study. J Biol Chem 1994;269:28584-28590.
8. Nieminen MS, Akkila J, Hasenfuss G, Kleber FX, Lehtonen LA, Mitrovic V, Nyquist O, Remme WJ. Hemodynamic and neurohumoral effects of continuous infusion of levosimendan in patients with congestive heart failure. J Am Coll Cardiol 2000;36:1903-1912. (Pubitemid 30844104)
9. Slawsky MT, Colucci WS, Gottlieb SS, Greenberg BH, Haeusslein E, Hare J, Hutchins S, Leier CV, LeJemtel TH, Loh E, Nicklas J, Ogilby D, Singh BN, Smith W. Acute hemodynamic and clinical effects of levosimendan in patients with severe heart failure. Study investigators. Circulation 2000;102: 2222-2227.
10. Follath F, Cleland JG, Just H, Papp JG, Scholz H, Peuhkurinen K, Harjola VP, Mitrovic V, Abdalla M, Sandell EP, Lehtonen L. Efficacy and safety of intravenous levosimendan compared with dobutamine in severe low-output heart failure (the LIDO study): a randomised double-blind trial. Lancet 2002;360:196-202.
11. Moiseyev VS, Poder P, Andrejevs N, Ruda MY, Golikov AP, Lazebnik LB, Kobalava ZD, Lehtonen LA, Laine T, Nieminen MS, Lie KI. Safety and efficacy of a novel calcium sensitizer, levosimendan, in patients with left ventricular failure due to an acute myocardial infarction. A randomized, placebo-controlled, double-blind study (RUSSLAN). Eur Heart J 2002;23:1422-1432.
12. Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Poder P, Kivikko M. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE randomized trial. JAMA 2007;297:1883-1891.
13. Nanas JN, Papazoglou P, Tsagalou EP, Ntalianis A, Tsolakis E, Terrovitis JV, Kanakakis J, Nanas SN, Alexopoulos GP, Anastasiou-Nana MI. Efficacy and safety of intermittent, long-term, concomitant dobutamine and levosimendan infusions in severe heart failure refractory to dobutamine alone. Am J Cardiol 2005;95:768-771.
14. Mavrogeni S, Giamouzis G, Papadopoulou E, Thomopoulou S, Dritsas A, Athanasopoulos G, Adreanides E, Vassiliadis I, Spargias K, Panagiotakos D, Cokkinos DV. A 6-month follow-up of intermittent levosimendan administration effect on systolic function, specific activity questionnaire, and arrhythmia in advanced heart failure. J Card Fail 2007;13:556-559.
15. Parissis JT, Adamopoulos S, Farmakis D, Filippatos G, Paraskevaidis I, Panou F, Iliodromitis E, Kremastinos DT. Effects of serial levosimendan infusions on left ventricular performance and plasma biomarkers of myocardial injury and neuro-hormonal and immune activation in patients with advanced heart failure. Heart 2006;92:1768-1772.
16. Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. The task force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European society of cardiology. Developed in collaboration with the heart failure association of the ESC (HFA) and endorsed by the European society of intensive care medicine (ESICM). Eur J Heart Fail 2008;10:933-989.
17. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002;166:111-117.
18. Parissis JT, Papadopoulos C, Nikolaou M, Bistola V, Farmakis D, Paraskevaidis I, Filippatos G, Kremastinos D. Effects of levosimendan on quality of life and emotional stress in advanced heart failure patients. Cardiovasc Drugs Ther 2007; 21:263-268. (Pubitemid 47387467)
19. Rasanen P, Roine E, Sintonen H, Semberg-Konttinen V, Ryynanen OP, Roine R. Use of quality-adjusted life years for the estimation of effectiveness of health care: a systematic literature review. Int J Technol Assess Health Care 2006;22:235-241.
20. Toller W, Knez I. Medical support and surgery of the failing heart: levosimendan. Scand J Surg 2007;96:121-124.
21. Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002;346:1845-1853.
22. Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC. Effects of multi-site biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med 2001;344:873-880.
23. Auricchio A, Stellbrink C, Sack S, Block M, Vogt J, Bakker P, Huth C, Schondube F, Wolfhard U, Bocker D, Krahnefeld O, Kirkels H. Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. J Am Coll Cardiol 2002;39: 2026-2033. (Pubitemid 34628286)
24. Unverferth DV, Magorien RD, Lewis RP, Leier CV. Long-term benefit of dobuta-mine in patients with congestive cardiomyopathy. Am Heart J 1980;100:622-630.
25. Applefeld MM, Newman KA, Grove WR, Sutton FJ, Roffman DS, Reed WP, Linberg SE. Intermittent, continuous outpatient dobutamine infusion in the management of congestive heart failure. Am J Cardiol 1983;51:455-458.
26. Krell MJ, Kline EM, Bates ER, Hodgson JM, Dilworth LR, Laufer N, Vogel RA, Pitt B. Intermittent, ambulatory dobutamine infusions in patients with severe congestive heart failure. Am Heart J 1986;112:787-791.
27. Oliva F, Latini R, Politi A, Staszewsky L, Maggioni AP, Nicolis E, Mauri F. Intermittent 6-month low-dose dobutamine infusion in severe heart failure: DICE multi-center trial. Am Heart J 1999;138:247-253.
28. Michaels AD, McKeown B, Kostal M, Vakharia KT, Jordan MV, Gerber IL, Foster E, Chatterjee K. Effects of intravenous levosimendan on human coronary vasomotor regulation, left ventricular wall stress, and myocardial oxygen uptake. Circulation 2005;111:1504-1509.
29. Parissis JT, Andreadou I, Bistola V, Paraskevaidis I, Filippatos G, Kremastinos DT. Novel biologic mechanisms of levosimendan and its effect on the failing heart. Expert Opin Investig Drugs 2008;17:1143-1150.
30. Follath F, Franco F, Cardoso JS. European experience on the practical use of levo-simendan in patients with acute heart failure syndromes. Am J Cardiol 2005;96: 80G-85G.
31. Lehtonen L, Poder P. The utility of levosimendan in the treatment of heart failure. Ann Med 2007;39:2-17.
32. Parle NM, Thomas MD, Dembo L, Best M, Driscoll GO. Repeated infusions of levosimendan: well tolerated and improves functional capacity in decompensated heart failure-a single-centre experience. Heart Lung Circ 2008; 17:206-210.
33. Kleber FX, Bollmann T, Borst MM, Costard-Jackle A, Ewert R, Kivikko M, Petterson T, Pohjanjousi P, Sonntag S, Wikstrom G. Repetitive dosing of intravenous levosimendan improves pulmonary hemodynamics in patients with pulmonary hypertension: results of a pilot study. J Clin Pharmacol 2009;49: 109-115.
34. Formiga F, Chivite D, Ortega C, Casas S, Ramon JM, Pujol R. End-of-life preferences in elderly patients admitted for heart failure. QJM 2004;97:803-808.