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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01595737
First received: May 7, 2012
Last updated: January 21, 2013
Last verified: May 2012
  Purpose

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 Intervention Phase
Cardiac Surgery
Drug: Levosimendan
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Rate of mortality

  • Morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Rate of morbidity


Secondary Outcome Measures:
  • Dose of inotropic drugs used [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Requirements for inotropic drugs

  • Dose of vasoactive drugs used [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Requirements for vasoactive drugs


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595737

Locations
Spain
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

No publications provided

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
Study First Received: May 7, 2012
Last Updated: January 21, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014