Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.

Phase 4

Completed

• Conditions: Myocardial Infarction; Heart Failure; Cardiogenic Shock
• Interventions: Drug: levosimendan; Drug: placebo,

• Registration Number: NCT00324766
• Lead Sponsor: Oslo University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-11
• Study Start: 2006-06
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	levosimendan	levosimendan
2	placebo,	Placebo, 1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min

Primary Outcome Measures

Name	Time	Method
Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms.	At 5 days	Changes in regional contractility (WMSI) measured by echo is the primary endpoint in the study and the sample size calculation is based on expected differenced in WMSI from baseline to day 5 between groups.

Secondary Outcome Measures

Name	Time	Method
Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months.	6 months
Time to rehospitalisation for decompensated heart failure.	6 months
Days hospitalised/days in intensive/coronary care.	At discharge
Changes in inflammation markers.	1, 5 days, 6 weeks.
Improvement in creatinine clearance.	5 days
Improvement of hemodynamic parameters.	5 days
Central venous oxygen saturation.	1 day
Total mortality.	6 months
Arrhythmias, hypotension, ischaemic episodes.	5 days
Change in proBNP	Baseline to day 5
Change in clinical symptom score	Baseline to day 5

Trial Locations

Locations (1)

Department of Cardiology, Ulleval University Hospital; 🇳🇴 Oslo, Norway