PMID- 17826646 OWN - NLM STAT- MEDLINE DCOM- 20070925 LR - 20181201 IS - 1532-8414 (Electronic) IS - 1071-9164 (Linking) VI - 13 IP - 7 DP - 2007 Sep TI - A 6-month follow-up of intermittent levosimendan administration effect on systolic function, specific activity questionnaire, and arrhythmia in advanced heart failure. PG - 556-9 AB - BACKGROUND: Levosimendan (LS) improves cardiac contractility without increasing myocardial oxygen demand. We administrated LS on a monthly intermittent 24-hour protocol and evaluated the clinical effect after 6 months in a randomized, open, prospective study. METHODS AND RESULTS: Fifty patients (age 45-65 years) with LV systolic dysfunction and New York Heart Association (NYHA) III or IV were randomized in 2 groups. LS group (n = 25) was compared with a control group (n = 25) matched for sex, age, and NYHA class. LS was given monthly on a 24-hour intravenous protocol for 6 months. Patients were evaluated by specific activity questionnaire (SAQ) and echocardiography (ECHO) before and 3 to 5 days after last drug administration, whereas 24-hour Holter recording was performed before and during last drug administration. Patients in LS and control group had same baseline SAQ, ECHO, and Holter parameters. At the end of the study, a larger proportion of patients in the levosimendan group reported improvement in symptoms (dyspnea and fatigue) (65% versus 20% in controls, P < .01). After 6 months, the LS group had a significant increase in LV ejection fraction versus controls (28 +/- 7 versus 21 +/- 4 %, P = .003), LV shortening fraction (15 +/- 3 versus 11 +/- 3 %, P = .006) and a decrease in mitral regurgitation (1.5 +/- 0.8 versus 2.7 +/- 0.6, P = .0001). There was no increase in supraventricular or ventricular beats or supraventricular tachycardia and VT episodes in LS group, compared with controls. Two patients from the LS group died in the 6-month follow-up period, compared with 8 patients in the control group (8% versus 32%, P < .05). CONCLUSIONS: A 6-month intermittent LS treatment in patients with decompensated advanced heart failure improved symptoms and LV systolic function. FAU - Mavrogeni, Sophie AU - Mavrogeni S AD - Onassis Cardiac Surgery Center, Athens, Greece. FAU - Giamouzis, Gregory AU - Giamouzis G FAU - Papadopoulou, Evangelia AU - Papadopoulou E FAU - Thomopoulou, Sophia AU - Thomopoulou S FAU - Dritsas, Athanasios AU - Dritsas A FAU - Athanasopoulos, George AU - Athanasopoulos G FAU - Adreanides, Elias AU - Adreanides E FAU - Vassiliadis, Ioannis AU - Vassiliadis I FAU - Spargias, Konstantinos AU - Spargias K FAU - Panagiotakos, Dimosthenis AU - Panagiotakos D FAU - Cokkinos, Dennis V AU - Cokkinos DV LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - J Card Fail JT - Journal of cardiac failure JID - 9442138 RN - 0 (Anti-Arrhythmia Agents) RN - 0 (Cardiotonic Agents) RN - 0 (Hydrazones) RN - 0 (Pyridazines) RN - 349552KRHK (Simendan) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Anti-Arrhythmia Agents/administration & dosage/*therapeutic use MH - Arrhythmias, Cardiac/complications/diagnostic imaging/*drug therapy/mortality/physiopathology MH - Cardiac Output, Low/complications/diagnostic imaging/*drug therapy/mortality/physiopathology MH - Cardiotonic Agents/administration & dosage/*therapeutic use MH - Drug Administration Schedule MH - Echocardiography MH - Electrocardiography, Ambulatory MH - Female MH - Follow-Up Studies MH - Humans MH - Hydrazones/administration & dosage/*therapeutic use MH - Middle Aged MH - Mitral Valve Insufficiency/complications/physiopathology MH - Myocardial Contraction MH - Pyridazines/administration & dosage/*therapeutic use MH - Simendan MH - Stroke Volume MH - Surveys and Questionnaires MH - Systole MH - Ventricular Dysfunction, Left/complications/diagnostic imaging/physiopathology MH - Ventricular Function, Left/*drug effects EDAT- 2007/09/11 09:00 MHDA- 2007/09/26 09:00 CRDT- 2007/09/11 09:00 PHST- 2006/04/29 00:00 [received] PHST- 2007/03/24 00:00 [revised] PHST- 2007/04/17 00:00 [accepted] PHST- 2007/09/11 09:00 [pubmed] PHST- 2007/09/26 09:00 [medline] PHST- 2007/09/11 09:00 [entrez] AID - S1071-9164(07)00132-7 [pii] AID - 10.1016/j.cardfail.2007.04.004 [doi] PST - ppublish SO - J Card Fail. 2007 Sep;13(7):556-9. doi: 10.1016/j.cardfail.2007.04.004.