Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00324766
First received: May 10, 2006
Last updated: June 25, 2012
Last verified: June 2012

May 10, 2006
June 25, 2012
June 2006
September 2011   (final data collection date for primary outcome measure)
Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms. [ Time Frame: At 5 days ] [ Designated as safety issue: No ]
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.
  • Efficacy: Changes in regional contractility, BNP and clinical symptoms. Safety:
  • Hypotension: BP< 90 mmHg or a drop in MAP >10 mmHg in patients in cardiogenic shock.
  • Ventricular arrhythmias.
  • Atrial fibrillation.
  • Tachycardia (heart rate above 120).
  • Ischaemic episodes.
Complete list of historical versions of study NCT00324766 on ClinicalTrials.gov Archive Site
  • Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Time to rehospitalisation for decompensated heart failure. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Days hospitalised/days in intensive/coronary care. [ Time Frame: At discharge ] [ Designated as safety issue: No ]
  • Changes in inflammation markers. [ Time Frame: 1, 5 days, 6 weeks. ] [ Designated as safety issue: No ]
  • Improvement in creatinine clearance. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Improvement of hemodynamic parameters. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Central venous oxygen saturation. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Total mortality. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Arrhythmias, hypotension, ischaemic episodes. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Change in proBNP [ Time Frame: Baseline to day 5 ] [ Designated as safety issue: No ]
  • Change in clinical symptom score [ Time Frame: Baseline to day 5 ] [ Designated as safety issue: No ]
  • Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months.
  • Time to rehospitalisation for decompensated heart failure.
  • Days hospitalised/days in intensive(coronary care.
  • Changes in inflammation markers.
  • Changes in hemostasis markers.
  • Improvement creatinine clearance.
  • In a subgroup of patients in cardiogenic shock:
  • Improvement of hemodynamic parameters.
  • Central venous oxygen saturation.
  • Total mortality.
  • Need for IV inotropes.
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Heart Failure
  • Cardiogenic Shock
  • Drug: levosimendan
    1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
    Other Name: Simdax
  • Drug: placebo,
    24 h, infusion
    Other Name: placebo
  • Active Comparator: 1
    levosimendan
    Intervention: Drug: levosimendan
  • Placebo Comparator: 2
    Placebo, 1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
    Intervention: Drug: placebo,
Husebye T, Eritsland J, Müller C, Sandvik L, Arnesen H, Seljeflot I, Mangschau A, Bjørnerheim R, Andersen GØ. Levosimendan in acute heart failure following primary percutaneous coronary intervention-treated acute ST-elevation myocardial infarction. Results from the LEAF trial: a randomized, placebo-controlled study. Eur J Heart Fail. 2013 May;15(5):565-72. doi: 10.1093/eurjhf/hfs215. Epub 2013 Jan 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
March 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00324766
0105
Yes
Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Trygve Husebye, MD, Department of Cardiology, Ulleval University Hospital
Study Chair: Geir Ø Andersen, MD, PhD Department of Cardiology, Ulleval University Hospital
Oslo University Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP