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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01595737
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : March 12, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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%.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: Levosimendan Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
Study Start Date : February 2011
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Rate of mortality

  2. Morbidity [ Time Frame: 30 days ]
    Rate of morbidity

Secondary Outcome Measures :
  1. Dose of inotropic drugs used [ Time Frame: 30 days ]
    Requirements for inotropic drugs

  2. Dose of vasoactive drugs used [ Time Frame: 30 days ]
    Requirements for vasoactive drugs

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595737

Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01595737     History of Changes
Other Study ID Numbers: ACA-SPAI-2008-20
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: May 2012

Additional relevant MeSH terms:
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs