Intracoronary Administration of Levosimendan in Cardiac Surgery Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Tampere University Hospital
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01500785
First received: December 22, 2011
Last updated: April 7, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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:
  • Simdax (manufacturer: Orion Corporation)
  • CO1CX08
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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500785

Contacts
Contact: Panu Virkkala, MD +358331165079 panu.virkkala@sydankeskus.fi

Locations
Finland
Heart Center Co. Tampere university hospital Recruiting
Tampere, Finland, 33521
Contact: Kati Peltomaki    +358504361303    kati.peltomaki@sydankeskus.fi   
Principal Investigator: Panu Virkkala, MD         
Sponsors and Collaborators
Tampere University Hospital
Investigators
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 7, 2014
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Myocardial Stunning
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Hydroxocobalamin
Simendan
Vitamin B 12
Vitamin B Complex
Vitamins
Anti-Arrhythmia Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014