Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery

AHEPA University Hospital

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Levosimendan infusion; Drug: Placebo infusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01318460

AHEPA_CTS-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
• age < 79 years old
• left ventricular ejection fraction <= 40%
• informed patient's consent

Exclusion criteria

• age < 18 years old
• emergency surgery
• medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
• any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
• need for valvular replacement surgery
• redo surgery
• serum creatinine > 2 mg/dl
• history of malignant cardiac arrhythmias

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Levosimendan

Active Comparator group

Description:

Patients treated with prophylactic administration of levosimendan

Treatment:

Drug: Levosimendan infusion

Placebo group

Placebo Comparator group

Description:

Patients managed with placebo administration

Treatment:

Drug: Placebo infusion