Coronary Artery Disease Clinical Trial
Official title:
Prophylactic Administration of Levosimendan in Patients With Impaired Left Ventricular Function Undergoing Coronary Surgery
The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.
Myocardial revascularization in patients with impaired left ventricular function remains a
serious problem in cardiac surgery. Despite the recent developments with the use of new
surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative
morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic
drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important
improvement to the hemodynamic status of these patients, but they have not considerably
decreased mortality. These drugs owe their positive inotropic action to the increase of
intracellular calcium and thereafter they improve the myocardial function.
Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial
contractility without particular promotion of the intracellular calcium accumulation.
Contemporary experimental and clinical data demonstrated the effectiveness of this drug in
the reduction of surgical mortality to the patients with low left ventricular ejection
fraction (LVEF) who undergo coronary artery bypass grafting (CABG).
This is an original prospective randomized controlled study focused on the preoperative use
of this drug in patients with impaired left ventricular function which is associated with a
high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly
evident in this cohort of patients. Prophylactic administration of levosimendan the day
before the operation could be translated in improved myocardial performance intraoperatively
and during the early postoperative period.
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