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

NCT01595737 | Completed Phase 4 DMC

• 1 other identifier: ACA-SPAI-2008-20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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%.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• Mortality

  Rate of mortality

  30 days

• Morbidity

  Rate of morbidity

  30 days

Secondary Outcomes (2)

• Dose of inotropic drugs used

  30 days

• Dose of vasoactive drugs used

  30 days

Study Arms (2)

Levosimendan

EXPERIMENTAL

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levosimendan DRUG

Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.

Levosimendan

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Interventions

Simendan

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 10, 2012
• Study Start: February 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 12, 2015

Record last verified: 2012-05

Locations

ES (1)