OBJECTIVES:Oral levosimendan improves ventricular function in short-term clinical trials. The effects of long-term treatment with oral levosimendan were investigated on echocardiographic parameters of left ventricular function in patients with chronic heart failure. DESIGN:Twenty-nine patients with NYHA III-IV congestive chronic HF were prospectively enrolled in a randomised, double-blind, placebo controlled study. Oral levosimendan was administered on top of existing medication over a treatment period of at least 180 days. Echocardiographic measurements estimating pulmonary capillary wedge pressure (PCWP) and tissue Doppler mitral basal myocardial velocities (Sm, Em) were performed at baseline and 90 and 180 days after randomisation. RESULTS:Estimated PCWP at baseline was elevated in both groups and decreased by 13% in the levosimendan group compared to an increase of 9% in the placebo group (p = 0.035). Sm was decreased in both groups at baseline and improved by 0.9 cm/s in the levosimendan group and decreased by 0.1 cm/s in the placebo group (p = 0.035). Levosimendan did not significantly alter heart rate or systolic blood pressure. CONCLUSIONS:Oral levosimendan improved hemodynamic function in chronic heart failure patients and the effect was sustained over the 180-day follow-up period.
RCT Entities:
OBJECTIVES: Oral levosimendan improves ventricular function in short-term clinical trials. The effects of long-term treatment with oral levosimendan were investigated on echocardiographic parameters of left ventricular function in patients with chronic heart failure. DESIGN: Twenty-nine patients with NYHA III-IV congestive chronic HF were prospectively enrolled in a randomised, double-blind, placebo controlled study. Oral levosimendan was administered on top of existing medication over a treatment period of at least 180 days. Echocardiographic measurements estimating pulmonary capillary wedge pressure (PCWP) and tissue Doppler mitral basal myocardial velocities (Sm, Em) were performed at baseline and 90 and 180 days after randomisation. RESULTS: Estimated PCWP at baseline was elevated in both groups and decreased by 13% in the levosimendan group compared to an increase of 9% in the placebo group (p = 0.035). Sm was decreased in both groups at baseline and improved by 0.9 cm/s in the levosimendan group and decreased by 0.1 cm/s in the placebo group (p = 0.035). Levosimendan did not significantly alter heart rate or systolic blood pressure. CONCLUSIONS: Oral levosimendan improved hemodynamic function in chronic heart failurepatients and the effect was sustained over the 180-day follow-up period.
Authors: Simona Silvetti; Teresa Greco; Ambra Licia Di Prima; Marta Mucchetti; Castro Maria de Lurdes; Laura Pasin; Mara Scandroglio; Giovanni Landoni; Alberto Zangrillo Journal: Clin Res Cardiol Date: 2013-12-25 Impact factor: 5.460