NCT00324766

Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.

Safety and Efficacy of Levosimendan in Patients With Acute Myocardial Infarction Complicated by Symptomatic Left Ventricular Failure.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Myocardial Infarction
• Heart Failure
• Cardiogenic Shock

Interventions

Type	Name	Description
DRUG	levosimendan	1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
DRUG	placebo,	24 h, infusion

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2006-05-11
• Last updated: 2012-06-26

Locations

1 site across 1 country: Norway