Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
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Purpose
Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial dysfunction. It has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium. Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function. Systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan. Colucci et al have demonstrated that with intracoronary administration of milrinone, another inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by adding levosimendan into cardioplegia solution.
The investigators hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline. Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Stunning |
Drug: levosimendan Drug: Vitamin B 12 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intracoronary Administration of Levosimendan in Cardiac Surgery Patients |
- change in cardiac output [ Time Frame: from baseline to 15min after weaning from CPB ] [ Designated as safety issue: No ]Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).
- EF [ Time Frame: from baseline to 5 min after sternal closure ] [ Designated as safety issue: No ]Secondary endpoint is a change in LV ejection fraction (EF) from baseline (after induction of anesthesia) to 5 min after sternal closure.
- cTnT/CK-MB on the first postoperative morning. [ Time Frame: from baseline to 1st post. op. morning ] [ Designated as safety issue: No ]Secondary endpoint is a change in cTnT/CK-MB on the first postoperative morning.
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: levosimendan |
Drug: levosimendan
infusion; levosimendan (12 μg/kg) The study drug will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient)
Other Names:
|
| Placebo Comparator: placebo |
Drug: Vitamin B 12
Infusion made of Glucos B.Braun 50 mg/ml infusion together with vitamin B12 which is used to colour the glucose infusion to look identical to Simdax infusion The placebo will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient).
Other Name: Soluvit (B05XC)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- preoperative LVEF 40% or less
- septal wall thickness more than 11mm
- less than moderate aortic insufficiency
- sinus rhythm before CPB
Exclusion Criteria:
- oesophageal disease
- known allergy to levosimendan or its metabolites or adjuvants.
Contacts and Locations| Contact: Panu Virkkala, MD | +358331165079 | panu.virkkala@sydankeskus.fi |
| Finland | |
| Heart Center Co. Tampere university hospital | Recruiting |
| Tampere, Finland, 33521 | |
| Contact: Kati Peltomaki +358504361303 kati.peltomaki@sydankeskus.fi | |
| Principal Investigator: Panu Virkkala, MD | |
| Principal Investigator: | Panu Virkkala, MD | Heart Center Co. Tampere university hospital |
More Information
No publications provided
| Responsible Party: | Tampere University Hospital |
| ClinicalTrials.gov Identifier: | NCT01500785 History of Changes |
| Other Study ID Numbers: | HCA-2011-1-3, 2011-002643-10 |
| Study First Received: | December 22, 2011 |
| Last Updated: | April 13, 2012 |
| Health Authority: | Finland: Finnish Medicines Agency |
Additional relevant MeSH terms:
|
Myocardial Stunning Myocardial Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Vitamin B 12 Hydroxocobalamin Vitamin B Complex Vitamins Simendan Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Cardiotonic Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013