Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting
Brief Summary: Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (AVR) together with coronary artery bypass grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will be carried out in Heart Center.

Twenty four patients will be randomized into two groups of 12. The treatment group will receive 24 hour infusion of levosimendan preoperatively where as the placebo group will receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn, Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate, cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be carried out as in standard care. Echo cardiography will be done pre- and postoperatively. Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24 hours.


Options:
A: Inclusion Criteria:

* age ≥18 years
* intention to perform first-time multi-vessel CABG

Exclusion Criteria:

* unstable angina
* valvular disease
* diabetes mellitus treated with sulphonylurea drugs
* renal failure
* severe hepatic disease
* severe chronic obstructive pulmonary disease
* a history of prior CABG surgery
* recent myocardial infarction (MI) within the previous month
B: Inclusion Criteria:

* LVEF less than 50% of left ventricular hypertrophy indicated by wall thickness more than 12mm

Exclusion Criteria:

* allergy to levosimendan
C: Inclusion Criteria:

* Adult patients scheduled for elective valvular or complex (2 or more valves or
* valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or
* systolic pulmonary artery pressure (SPAP) over 40 mmHg (using preoperative right-sided catheterization or estimated by echocardiography).

Exclusion Criteria:

* Cardiac surgery not requiring CPB, contraindication to TEE (esophageal pathology or unstable cervical spine) and emergency surgery.
* Patients will be recruited the day before surgery and randomized using computerized cards by the pharmacy department
D: Inclusion Criteria:

* Documented LVEF ≤35% measured by ventriculogram, echocardiogram (ECHO), nuclear scan, or MRI within 60 days before surgery.
* Scheduled or urgent 1) CABG surgery, 2)CABG with aortic valve surgery, 3) CABG with mitral valve surgery, or 4) mitral valve surgery with or without other valves
* Surgery will employ CPB pump
* Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return.
* Evidence of systemic bacterial, systemic fungal, or viral infection within 72 hours before surgery.
* Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration).
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2.
* Weight ≥ 170 kg.
* Patients whose SBP cannot be managed to ensure SBP \> 90 mmHg at initiation of study drug.
* Heart rate ≥ 120 bpm, persistent for at least 10 minutes screening and unresponsive to treatment.
* Hemoglobin \< 80 g/L.
* Serum potassium \< 3.5 mmol/L and \> 5.5 mmol/L at baseline.
* A history of Torsades de Pointes.
* Mechanical assist device (IABP, LVAD, ECMO) in the patient at the start of surgery or pre-planned to be inserted during surgery before coming off CPB.
* Patients with aortal femoral occlusive disease that would prohibit use of IABP unless VAD or ECMO not available.
* Liver dysfunction Child Pugh Class B or C
* Patients having severely compromised immune function
* Pregnant, suspected to be pregnant, or breast-feeding.
* Received an experimental drug or used an experimental medical device in previous 30 days.
* Known allergic reaction or sensitivity to Levosimendan or excipients.
* Received commercial Levosimendan within 30 days before the planned start of study drug.
* Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Answer: B