NCT01188369

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diastolic Dysfunction
• Left Ventricular Hypertrophy

Interventions

Type	Name	Description
DRUG	levosimendan	Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.
DRUG	placebo drug	Intravenous infusion, colour identical to levosimendan

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-08-25
• Last updated: 2018-12-03
• Results posted: 2018-12-03

Locations

1 site across 1 country: Denmark