Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

NCT ID: NCT01500785

Last Updated: 2019-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2019-09-11

Brief Summary

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.

Conditions

Myocardial Stunning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

levosimendan

Group Type: ACTIVE_COMPARATOR

levosimendan

Intervention Type: DRUG

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)

placebo

Group Type: PLACEBO_COMPARATOR

Vitamin B 12

Intervention Type: DRUG

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).

Interventions

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)

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Simdax (manufacturer: Orion Corporation); CO1CX08; Soluvit (B05XC)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Panu Virkkala, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Co. Tampere university hospital

Locations

Heart Center Co. Tampere university hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

2011-002643-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HCA-2011-1-3

Identifier Type: -

Identifier Source: org_study_id