Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction. - Full Text View

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 IV

MedlinePlus related topics:

Heart Attack Heart Failure

ChemIDplus related topics:

Levosimendan Simendan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:

Efficacy: Changes in regional contractility, BNP and clinical symptoms. [ Time Frame: At 5 days ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment:	60
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator levosimendan	Drug: levosimendan 24 h infusion, 0.1 micrgr/kg/min
2: Placebo Comparator Placebo	Drug: placebo, 24 h, infusion

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

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

Contacts


Contact: Geir Ø Andersen, MD, PhD	+47-221119101	g.o.andersen@labmed.uio.no

Contact: Arild Mangschau, MD, PhD	+47-221119101	aman@ulleval.no

Locations


Norway
	Department of Cardiology, Ulleval University Hospital	Recruiting
	Oslo, Norway, N-0852
	Principal Investigator: Geir Ø Andersen, MD, PhD
	Sub-Investigator: Arild Mangschau, MD, PhD
	Sub-Investigator: Jan Eritsland, MD, PhD

Sponsors and Collaborators

Ullevaal University Hospital

Investigators


Principal Investigator:	Geir Ø Andersen, MD, PhD	Department of Cardiology, Ulleval University Hospital

Study Chair:	Arild Mangschau, MD, PhD	Department of Cardiology, Ulleval University Hospital

More Information

Responsible Party:	Ulleval University Hospital ( Geir Øystein Andersen )
Study ID Numbers:	0105
First Received:	May 10, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00324766
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Necrosis

Heart Failure

Heart Diseases

Shock

Shock, Cardiogenic

Myocardial Ischemia

Vascular Diseases

Ischemia

Infarction

Myocardial Infarction

Simendan

Additional relevant MeSH terms:

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Cardiotonic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Cardiovascular Agents

Protective Agents

Pharmacologic Actions

Pathologic Processes

Phosphodiesterase Inhibitors

Therapeutic Uses

Cardiovascular Diseases

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Ullevaal University Hospital
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00324766