Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.

Oslo University Hospital61 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Myocardial Infarction Heart Failure Cardiogenic Shock

Interventions

levosimendanDRUG

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

placebo,DRUG

24 h, infusion

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Cardiology, Ulleval University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms.

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.

Time frame: At 5 days

Secondary Outcomes

Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months.

Time frame: 6 months

Time to rehospitalisation for decompensated heart failure.

Time frame: 6 months

Days hospitalised/days in intensive/coronary care.

Time frame: At discharge

Changes in inflammation markers.

Time frame: 1, 5 days, 6 weeks.

Improvement in creatinine clearance.

Time frame: 5 days

Improvement of hemodynamic parameters.

Time frame: 5 days

Central venous oxygen saturation.

Time frame: 1 day

Total mortality.

Time frame: 6 months

Arrhythmias, hypotension, ischaemic episodes.

Time frame: 5 days

Change in proBNP

Data from ClinicalTrials.gov

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