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

University of Aarhus

Status and phase: Terminated; Phase 4

Conditions: Diastolic Dysfunction; Left Ventricular Hypertrophy

Treatments: Drug: placebo drug; Drug: levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT01188369

1616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

levosimendan

Experimental group

Description:

infusion 0,1ug/kg/min for duration of ca. 4 hours prior to operation and until the end of operation

Treatment:

Drug: levosimendan

Placebo

Placebo Comparator group

Description:

Identical placebo

Treatment:

Drug: placebo drug