Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

NCT01500785 | Terminated Phase 4

• 2 other identifiers: HCA-2011-1-32011-002643-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• EF

  from baseline to 5 min after sternal closure

• cTnT/CK-MB on the first postoperative morning.

  from baseline to 1st post. op. morning

Study Arms (2)

levosimendan

ACTIVE COMPARATOR

Drug: levosimendan

placebo

PLACEBO COMPARATOR

Drug: Vitamin B 12

Interventions

levosimendan 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)

Also known as: Simdax (manufacturer: Orion Corporation), CO1CX08

levosimendan

Vitamin B 12 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).

Also known as: Soluvit (B05XC)

placebo

Eligibility Criteria

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

You may qualify if:

• preoperative LVEF 40% or less
• septal wall thickness more than 11mm
• less than moderate aortic insufficiency
• sinus rhythm before CPB

You may not qualify if:

• oesophageal disease
• known allergy to levosimendan or its metabolites or adjuvants.

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Heart Center Co. Tampere university hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Myocardial Stunning

Interventions

Simendan; Vitamin B 12

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Panu Virkkala, MD

  Heart Center Co. Tampere university hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: June 15, 2018
• Primary Completion: December 15, 2018
• Study Completion: September 11, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

FI (1)