Conditions: Diastolic Dysfunction Left Ventricular Hypertrophy
Keywords: levosimendan heart failure inotropics diastolic dysfunction left ventricular hypertrophy aortic valve stenosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation arm 2: Identical placebo

Interventions: intervention 1: levosimendan intervention 2: placebo drug
Intervention descriptions: intervention 1: Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation. intervention 2: Intravenous infusion, colour identical to levosimendan

Protocol document: