Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy

Effects of Levosimendan on Systolic Deformation and Diastolic Function in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy

This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.

Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:

• Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion
• Immediately before surgery
• After induction of anaesthesia and before "knife time" = start of surgery.
• At the end of surgery: Levosimendan infusion will stop.
• Approximately 4 hours after surgery immediately before extubation.
• Approximately 21 hours after surgery
• Approximately 96 hours after surgery (day 4)
• 6 months after surgery

Outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.

Interim analysis will be conducted after 30 included patients.

Inclusion Criteria:

• Eligible for aortic valve replacement
• EF > 45%
• Left ventricular posterior wall > 12mm
• Sinus rhythm

Exclusion Criteria:

• Concomitant bypass operation
• Severe mitral insufficiency
• Active endocarditis
• Insufficient ultrasound opportunity
• Systolic blood pressure < 100 mmHg
• moderate-severe renal failure
• allergy to levosimendan
• lack of patient consent Pregnancy or status of lactating
• Fertile women who do not use relevant anticonception