Status:
COMPLETED
Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.
Lead Sponsor:
Oslo University Hospital
Conditions:
Myocardial Infarction
Heart Failure
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 corona...
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 defi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00324766
Start Date
June 1 2006
End Date
March 1 2012
Last Update
June 26 2012
Active Locations (1)
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1
Department of Cardiology, Ulleval University Hospital
Oslo, Norway, N-0852