Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction; Heart Failure; Cardiogenic Shock

Treatments: Drug: levosimendan; Drug: placebo,

Study type: Interventional

Funder types: Other

Identifiers

NCT00324766

0105 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment.

Full description

Double blind placebo-controlled study with parallel groups in patients with acute PCI treated myocardial infarction complicated with decompensated heart failure. The study include a prospectively defined subgroup of patients in cardiogenic shock. Treating acute myocardial infarction with PCI restores blood flow, but decreased contractility remains for hours and days due to stunned myocardium. Levosimendan has both inotropic and vasodilatory effects which could support the failing heart after treating the acute myocardial infarction with PCI and may improve myocardial stunning and decrease pro-inflammatory cytokines. Levosimendan could improve myocardial contractility, symptoms and outcome without adverse effects. The aims of the study are to investigate whether a 24 hour infusion with levosimendan could improve regional contractility measured by echocardiography, improve BNP levels, reduce the levels of pro-inflammatory cytokines and improve symptoms in patients with acute decompensated heart failure during the first 24 hours after acute PCI.

Enrollment: 61 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute ST-elevation myocardial infarction subject to acute PCI or non-ST elevation myocardial infarction subject to PCI within 72 hours after start of chest pain and:
• Revascularization by PCI,
• Signs of decreased wall-motion in at least 3 of 16 segments of the left ventricle
• Dyspnoea at rest and one of the following:

pulmonary edema, pulmonary congestion,need for CPAP or ventilator, need for IC diuretics or oliguria.

Subgroup of patients in cardiogenic shock: Systolic BP below 90 after 1 hour of volume therapy.

Exclusion criteria

• Age below 20 years
• Heart rate above 120 bpm
• Septic shock
• ARDS
• Creatinine >450 micromol/l
• Hepatic impairment
• Significant mechanical outlet obstruction
• Allergy against study drug medication
• Anaemia (Hb <8 g/dl)
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

levosimendan

Treatment:

Drug: levosimendan

2

Placebo Comparator group

Description:

Placebo, 1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min

Treatment:

Drug: placebo,