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

Abbott

Status and phase

Completed

Phase 3

Conditions

Heart Failure, Congestive

Treatments

Drug: Levosimendan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00048425

3001069

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.