Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324766
• Other study ID #: 0105
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2006
• Last updated: June 25, 2012
• Start date: June 2006
• Est. completion date: March 2012

Study information

• Verified date: June 2012
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiogenic Shock
• Heart Failure
• Infarction
• Myocardial Infarction
• Shock, Cardiogenic

Intervention

Drug:
• levosimendan
1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
• placebo,
24 h, infusion

Locations

Country	Name	City	State
Norway	Department of Cardiology, Ulleval University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 5 days	No
Secondary	Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months.		6 months	Yes
Secondary	Time to rehospitalisation for decompensated heart failure.		6 months	Yes
Secondary	Days hospitalised/days in intensive/coronary care.		At discharge	No
Secondary	Changes in inflammation markers.		1, 5 days, 6 weeks.	No
Secondary	Improvement in creatinine clearance.		5 days	Yes
Secondary	Improvement of hemodynamic parameters.		5 days	Yes
Secondary	Central venous oxygen saturation.		1 day	No
Secondary	Total mortality.		6 months	Yes
Secondary	Arrhythmias, hypotension, ischaemic episodes.		5 days	Yes
Secondary	Change in proBNP		Baseline to day 5	No
Secondary	Change in clinical symptom score		Baseline to day 5	No