Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.

Official Title

Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

Conditions

Heart Failure, Congestive

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Further Details

Study Start

October 31, 2002

Eligibility & Criteria

Genders Eligible for Study: Both Criteria:Inclusion Criteria:- A written informed consent must be obtained for hospitalized male or female patients over 18 years old of age. – The eligible patients must be diagnosed with worsening heart failure as evidenced by dyspnea at rest, poor ejection fraction and have been treated with IV diuretics. – It is allowable for the patients to be treated with IV inotropes and vasodilators. Exclusion Criteria: The following criteria would exclude the patient from study:- invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiac re-synchronization)- rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate)- severe ventricular outflow obstruction- angina- hypotension- uncorrected hypokalemia, – CNS (e.g. stroke, TIA)- respiratory (e.g. COPD, intubated patients, oral- intravenous or intramuscular steroids)- renal insufficiency (e.g. increased serum creatinine, dialysis) – hepatic impairment (e.g. significant increase in liver enzymes)- decompensation from active infection and acute bleeding (e.g. severe anemia). – Female patients of child bearing potential must have a negative pregnancy test and use adequate contraceptive precautions. – Also excluded is the use of amrinone and milrinone prior to randomization, a history of hypersensitivity to levosimendan or any of the excipients and previous participation in a clinical trial with any experimental treatment within the last 30 days.

Total Enrolment

Contact Details

[1] Australia, Australian Capital Territory Canberra Hospital/Cardiology Department, Garran, Australian Capital Territory, 2605, Australia; Recruiting [2] Australia, New South Wales Concord Hospital – Heart Failure Clinic/Department of Cardiology, Concord, New South Wales, NSW 2139, Australia; Recruiting Royal North Shore Hospital – Cardiology Department, St. Leonards, New South Wales, Australia; Recruiting Prince of Wales Hospital, Randwick, New South Wales, Australia; Recruiting Gosford Hospital, Gosford, New South Wales, Australia; Recruiting Royal Prince Alfred Hospital/Department of Cardiology, Camperdown, New South Wales, 2050, Australia; Recruiting St. George Hospital/Cardiology Department, Sydney, New South Wales, Australia; Recruiting Liverpool Hospital – Cardiology Research, Liverpool, New South Wales, 2116, Australia; Recruiting [3] Australia, Queensland Royal Brisbane Hospital – Cardiology Department, HERSTON, Queensland, QLD 4029, Australia; Recruiting The Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia; Recruiting [4] Australia, South AustraliaFlinders Medical Centre – Cardiac Research Department, Bedford Park, South Australia, Australia; Recruiting Queen Elizabeth Hospital/Cardiology Department, Woodville, South Australia, 5011, Australia; Recruiting [5] Australia, TasmaniaRoyal Hobart Hospital, Hobart, Tasmania, 7000, Australia; Recruiting Launceston General Hospital/Cardiac Research Unit, Launceston, Tasmania, 7250, Australia; Recruiting [6] Australia, Victoria Box Hill Hospital – Coronary Care Unit, Box Hill, Victoria, Australia; Recruiting St. Vincent’s Hospital – Cardiology Investigational Unit, Fitzroy, Victoria, Australia; Recruiting Level 2, Cardiology Department/Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia; Recruiting Karinia House/Geelong Hospital, Geelong, Victoria, 3220, Australia; Recruiting [7] Australia, Western AustraliaHeart Research Institute/Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia; Recruiting