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

Completed · Phase 3

Conditions studied: Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT00048425

Run by

Abbott

People needed

600

Starts

2002-09-01

Expected to finish

2004-12-01

Last updated by the study team

2006-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cardiology, P.C. Research — Birmingham, Alabama, United States
• University Alabama at Birmingham — Birmingham, Alabama, United States
• Oracle Research-The Heart Center — Huntsville, Alabama, United States
• Providence Hospital Heart Failure Clinic — Mobile, Alabama, United States
• Arizona Heart Institute — Phoenix, Arizona, United States
• Sarver Heart Center - University of Arizona Health Science — Tucson, Arizona, United States
• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Central Cardiology Medical Center — Bakersfield, California, United States
• Cardiovascular Medical Group & Research Institute — Beverly Hills, California, United States
• San Diego Cardiovascular Research — Encinitas, California, United States
• Apex Cardiology Consultants, Inc. — Inglewood, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Los Angeles County/USC Medical Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Merced Heart Associates — Merced, California, United States
• A.R.I. Clinical Trials, Inc. — Redondo Beach, California, United States
• Sacramento Heart and Vascular Research Center — Sacramento, California, United States
• UCSD Medical Center, University of California — San Diego, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• VA Hospital of San Francisco — San Francisco, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Cardiovascular Associates/Office of Clinical Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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