Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

Inclusion criteria

• Male or female > 18 years and < 85 years.
• LVEF ≤ 35%
• Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
• Freely choose to participate in trial and sign an informed consent

Exclusion criteria

• The patient does not accept the protocol.
• Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
• Severe hypotension or severe tachycardia prior to entering study.
• Significant mechanical obstruction affecting ventricular filling and/or emptying.
• History of Torsades.
• Requirement for inotropic or vasoactive drugs or any type of mechanical assistance for 48 hours prior to surgery.
• Onset of angina or acute myocardial infarction within 48 hours prior to surgery, or cardiogenic shock.
• Surgery needs that are different from those planned.
• Chronic or severe kidney failure requiring haemodialysis or peritoneal dialysis or creatinine clearance values below 30ml/min or presence of nephrotic syndrome.
• Liver failure with transaminases 4 times above the normal maximum value.
• The patient must undergo a concurrently scheduled surgery, such as for a valve other than the mitral.
• When a screening cannot be performed at least during the 24 hours before surgery.
• Uncontrolled diabetes mellitus (blood glucose > 24mmol/l or 432mg/dl).
• History of any disease over the last five years that may compromise the patient's life, other than their heart disease.
• The patient is currently abusing alcohol or toxic substances.
• Presence of any other medical or psychiatric condition that the researcher believes makes a candidate ineligible for the study.
• Women with childbearing potential who are not using an effective contraception method.
• Participation in the last 30 days in any other study with either experimental drugs or devices.
• Body Mass Index (BMI) greater than 35.
• Administration of levosimendan in the last 30 days.