Safety and efficacy of levosimendan in patients with acute myocardial infarction complicated by symptomatic left ventricular failure

• Conditions: Patients with acute myocardial infarction developing acute heart failure after primary PCI (percutaneus coronary intervention). Some patients in a predefined subgroup are categorized as patients in cardiogenic shock. See study protocol (2) for details.

• Registration Number: EUCTR2004-002732-25-NO
• Lead Sponsor: Geir Øystein Andersen, Department of Cardiology, Ulleval University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who are hospitalised with acute ST-segment elevation myocardial infarction (STEMI: ECG definition) subjected to acute PCI
or
patients with non-ST segment elevation myocardial infarction subjected to PCI within 72 hours after start of chest pain.

and all of the following (1-3)
oRevascularization by PCI with opening of an occluded coronary artery or balloon dilatation of a stenotic coronary artery presumed to be culprit lesion.
oLeft-ventricular ejection fraction (EF) must be less than 40% measured by echocardiography.
oDyspnoea at rest at screening and at least one of the following signs of left ventricular failure:
•Pulmonary edema
•Signs of marked pulmonary congestion on chest x-ray
•Need for continuous-elevated positive airway-pressure ventilation (CPAP) or mechanical ventilation
•Need for IV diuretics.
•Oliguria (<0.5 ml/kg/hour) as a sign of hypoperfusion of the kidneys after volume therapy.
Subgroup of patients with cardiogenic shock:
A prospectively defined subgroup included by stratified randomisation.

Additional inclusion criteria includes both of the following:
oSystolic BP <90 mmHg after 60 min of adequate volume therapy or systolic BP between 90 and 100 mmHg with inotropic support by catecholamine infusion
oSigns of hypoperfusion (low-output heart failure)
•Oliguria (diuresis <0.5 ml/kg/hour)
•Cold, clammy extremities
•Reduced consciousness

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

oAge below 20 years,
oHeart rate above 120 bpm
oSeptic shock
oARDS
oCreatinine >450 µmol/l
oHepatic impairment
oSignificant mechanical outlet obstruction
oAllergy against study drug medication or one of its ingredients
oAnaemia (Hb < 8 g/dl)
oPregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified