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
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Heart Failure
Cardiogenic Shock
Drug: levosimendan
Drug: placebo,
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Levosimendan in Patients With Acute Myocardial Infarction Complicated by Symptomatic Left Ventricular Failure.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 61
Study Start Date: June 2006
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
levosimendan
Drug: levosimendan
1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
Other Name: Simdax
Placebo Comparator: 2
Placebo, 1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
Drug: placebo,
24 h, infusion
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324766

Locations
Norway
Department of Cardiology, Ulleval University Hospital
Oslo, Norway, N-0852
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Trygve Husebye, MD, Department of Cardiology, Ulleval University Hospital
Study Chair: Geir Ø Andersen, MD, PhD Department of Cardiology, Ulleval University Hospital
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00324766     History of Changes
Other Study ID Numbers: 0105
Study First Received: May 10, 2006
Last Updated: June 25, 2012
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Shock
Shock, Cardiogenic
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014