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Clinical Trials/NCT01318460
NCT01318460CompletedPhase 4

Prophylactic Administration of Levosimendan in Patients With Impaired Left Ventricular Function Undergoing Coronary Surgery

AHEPA University Hospital1 site in 1 country32 target enrollmentStarted: March 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Left ventricular function

Study Overview

Brief Summary

The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.

Detailed Description

Myocardial revascularization in patients with impaired left ventricular function remains a serious problem in cardiac surgery. Despite the recent developments with the use of new surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important improvement to the hemodynamic status of these patients, but they have not considerably decreased mortality. These drugs owe their positive inotropic action to the increase of intracellular calcium and thereafter they improve the myocardial function.

Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation. Contemporary experimental and clinical data demonstrated the effectiveness of this drug in the reduction of surgical mortality to the patients with low left ventricular ejection fraction (LVEF) who undergo coronary artery bypass grafting (CABG).

This is an original prospective randomized controlled study focused on the preoperative use of this drug in patients with impaired left ventricular function which is associated with a high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly evident in this cohort of patients. Prophylactic administration of levosimendan the day before the operation could be translated in improved myocardial performance intraoperatively and during the early postoperative period.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
  • age < 79 years old
  • left ventricular ejection fraction <= 40%
  • informed patient's consent

Exclusion Criteria

  • age < 18 years old
  • emergency surgery
  • medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
  • any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
  • need for valvular replacement surgery
  • redo surgery
  • serum creatinine > 2 mg/dl
  • history of malignant cardiac arrhythmias

Arms & Interventions

Levosimendan

Active Comparator

Patients treated with prophylactic administration of levosimendan

Intervention: Levosimendan infusion (Drug)

Placebo group

Placebo Comparator

Patients managed with placebo administration

Intervention: Placebo infusion (Drug)

Outcomes

Primary Outcomes

Left ventricular function

Time Frame: Seventh postoperative day

Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day

Secondary Outcomes

  • Total ICU stay(1st-7th postoperative day)
  • Morbidity(1st-7th postoperative day)
  • Time on mechanical ventilation(1st-7th postoperative day)
  • Perioperative mortality(30 days postoperatively)
  • Inotropic support(1st-7th postoperative day)
  • Need for intraaortic balloon pump(1st-7th postoperative day)
  • Total length of hospital stay(1st-7th postoperative day)
  • Major adverse cardiovascular events(1st-7th postoperative day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kyriakos Anastasiadis

Head of Cardiothoracic Department

AHEPA University Hospital

Study Sites (1)

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