Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

Myocardial Stunning Clinical Trial

Official title:

Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01500785
• Other study ID #: HCA-2011-1-3
• Secondary ID: 2011-002643-10
• Status: Terminated
• Phase: Phase 4
• Start date: June 15, 2018
• Est. completion date: September 11, 2019

Study information

• Verified date: September 2019
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 11, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myocardial Stunning

Intervention

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)
• 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).

Locations

Country	Name	City	State
Finland	Heart Center Co. Tampere university hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cardiac output	Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).	from baseline to 15min after weaning from CPB
Secondary	EF	Secondary endpoint is a change in LV ejection fraction (EF) from baseline (after induction of anesthesia) to 5 min after sternal closure.	from baseline to 5 min after sternal closure
Secondary	cTnT/CK-MB on the first postoperative morning.	Secondary endpoint is a change in cTnT/CK-MB on the first postoperative morning.	from baseline to 1st post. op. morning