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

NCT ID: NCT01188369

Last Updated: 2018-12-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-03-31

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.

Conditions

Diastolic Dysfunction; Left Ventricular Hypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

levosimendan

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

Group Type: EXPERIMENTAL

levosimendan

Intervention Type: DRUG

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

Placebo

Identical placebo

Group Type: PLACEBO_COMPARATOR

placebo drug

Intervention Type: DRUG

Intravenous infusion, colour identical to levosimendan

Interventions

levosimendan

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

Intervention Type: DRUG

placebo drug

Intravenous infusion, colour identical to levosimendan

Intervention Type: DRUG

Other Intervention Names

Simdax; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Juhl-Olsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology

Locations

Department of Anaesthesiology

Århus N, Central Jutland, Denmark

Countries

Denmark

Other Identifiers

1616

Identifier Type: -

Identifier Source: org_study_id