Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF < 35%.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Drug: Levosimendan; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female > 18 years and < 85 years.
• LVEF ≤ 35%
• Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
• Freely choose to participate in trial and sign an informed consent

Exclusion Criteria:

• The patient does not accept the protocol.
• Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
• Severe hypotension or severe tachycardia prior to entering study.
• Significant mechanical obstruction affecting ventricular filling and/or emptying.
• History of Torsades.
• Requirement for inotropic or vasoactive drugs or any type of mechanical assistance for 48 hours prior to surgery.
• Onset of angina or acute myocardial infarction within 48 hours prior to surgery, or cardiogenic shock.
• Surgery needs that are different from those planned.
• Chronic or severe kidney failure requiring haemodialysis or peritoneal dialysis or creatinine clearance values below 30ml/min or presence of nephrotic syndrome.
• Liver failure with transaminases 4 times above the normal maximum value.
• The patient must undergo a concurrently scheduled surgery, such as for a valve other than the mitral.
• When a screening cannot be performed at least during the 24 hours before surgery.
• Uncontrolled diabetes mellitus (blood glucose > 24mmol/l or 432mg/dl).
• History of any disease over the last five years that may compromise the patient's life, other than their heart disease.
• The patient is currently abusing alcohol or toxic substances.
• Presence of any other medical or psychiatric condition that the researcher believes makes a candidate ineligible for the study.
• Women with childbearing potential who are not using an effective contraception method.
• Participation in the last 30 days in any other study with either experimental drugs or devices.
• Body Mass Index (BMI) greater than 35.
• Administration of levosimendan in the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo group patients will receive a perfusion of 5% glucose solution. This clear solution, free of visible particles, will have 0.4mg of riboflavin sodium phosphate, 100mg of anhydrous alcohol and water for injection up to 1ml added to it. This solution will be calculated as a dose of 0.1µg/kg/min.
Experimental: Levosimendan	Drug: Levosimendan; Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of mortality	30 days
Morbidity	Rate of morbidity	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose of inotropic drugs used	Requirements for inotropic drugs	30 days
Dose of vasoactive drugs used	Requirements for vasoactive drugs	30 days

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 7, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): March 12, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Simendan
• Other Study ID Numbers: ACA-SPAI-2008-20