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.
Conditions
Interventions
Trade Name: Simdax
Product Name: Simdax
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: levosimendan
Current Sponsor code: 0105
Concentration unit: µg/kg microgram(s)/k
Sponsors
Geir Øystein Andersen, Department of Cardiology, Ulleval University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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) o Revascularization by PCI with opening of an occluded coronary artery or balloon dilatation of a stenotic coronary artery presumed to be culprit lesion. o Left-ventricular ejection fraction (EF) must be less than 40% measured by echocardiography. o Dyspnoea 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 (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Age below 20 years, o Heart rate above 120 bpm o Septic shock o ARDS o Creatinine >450 µmol/l o Hepatic impairment o Significant mechanical outlet obstruction o Allergy against study drug medication or one of its ingredients o Anaemia (Hb < 8 g/dl) o Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and efficacy of a 24-hour infusion with levosimendan compared to placebo, in patients with acute myocardial infarction complicated with decompensated heart failure after acute revascularization by PCI. The main efficacy endpoints are changes in regional contractility of the myocardium (wall motion score index) measured by echocardiography, changes in brain natriuretic peptide and a clinical composite score evaluating changes in patients symptoms. Additional endpoints are safety endpoints: Hypotension, arrhythmias and ischaemic episodes.;Secondary Objective: Evaluate the effect of the IMP on the length of stay in coronary care unit and the total length of stay in hospital. Evaluate the effect of the IMP on rehospitalization, new myocardial infarction and mortality (MACE). Evaluate the effect of the IMP on infarct size measured by gated spect. Evaluate the effect of the IMP on inflammation markers, haemostasis parameters and serum lactate. In a subroup of patients in cardiogenic shock: Evaluate the effect of the IMP on days on intra-aortic-balloon counter pulsation treatment, in-hospital mortality, kidney function and central venous oxygen saturation.;Primary end point(s): Efficacy parameters: oChanges from baseline to 5 days in Wall motion score-index measured by echocardiography. oChanges from baseline to 5 days in BNP (Brain natriuretic peptide). oClinical composite at 5 days after start of the study drug infusion, according to the physician’s global assessment measured as change from baseline to 5 days. Safety parameters: Number of patients developing: oHypotension: BP 10 mm Hg in patients with cardiogenic shock. oTachcardia (heart rate above 120). oAtrial fibrillation. oVentricular arrhythmia (VT, VF, TDP). oIschaemic episodes (ECG changes or chest pain demanding treatment). | — |
Countries
Norway
Outcome results
None listed