Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT00048425
- Lead Sponsor
- Abbott
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (166)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Universtiy of PA Health System
🇺🇸Philadelphia, Pennsylvania, United States
Royal Prince Alfred Hospital/Department of Cardiology
🇦🇺Camperdown, New South Wales, Australia
Liverpool Hospital - Cardiology Research
🇦🇺Liverpool, New South Wales, Australia
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Miami Research & Education Foundation
🇺🇸Miami, Florida, United States
Clarian Health - Methodist Research Institute Inc.
🇺🇸Indianapolis, Indiana, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston VA Medical Center
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
The Lindner Center
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Sciences
🇺🇸San Antonio, Texas, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
VA Medical Center - Cardiology Department
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
VA Hospital of San Francisco
🇺🇸San Francisco, California, United States
Via Christi Research Inc. dba PriVia
🇺🇸Wichita, Kansas, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
A.R.I. Clinical Trials, Inc.
🇺🇸Redondo Beach, California, United States
Jacksonville Heart Center,PA
🇺🇸Jacksonville, Florida, United States
Victor Howard M.D., P.A. Heart Research Center
🇺🇸Port Charlotte, Florida, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
University Of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Geisinger Health System
🇺🇸Danville, Pennsylvania, United States
University Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Los Angeles County/USC Medical Center
🇺🇸Los Angeles, California, United States
San Diego Cardiovascular Research
🇺🇸Encinitas, California, United States
Merced Heart Associates
🇺🇸Merced, California, United States
Sacramento Heart and Vascular Research Center
🇺🇸Sacramento, California, United States
UCSD Medical Center, University of California
🇺🇸San Diego, California, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
Washington Hospital Center - Cardiac Surgery Department
🇺🇸Washington, District of Columbia, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
MIMA Century Research Associates
🇺🇸Melbourne, Florida, United States
The Ford Research Institute PA/NW Florida Heart Group PA
🇺🇸Pensacola, Florida, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Augusta Cardiology Clinic, P.C.
🇺🇸Augusta, Georgia, United States
University Hospitals Clinic
🇺🇸Columbus, Missouri, United States
Medical Research Institute
🇺🇸Slidell, Louisiana, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Montefiore Medical Center/Cardiology Department
🇺🇸Bronx, New York, United States
OSU Medical Center-Center Wellness & Prevention
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Foundation/Department of Cardiology
🇺🇸Cleveland, Ohio, United States
University Health Science Center/Cardio Section
🇺🇸Oklahoma City, Oklahoma, United States
Toledo Clinic & Outpatient Surgery/Department of Cardiology
🇺🇸Toledo, Ohio, United States
Elgin Cardiology Associates
🇺🇸Elgin, Illinois, United States
St. Vincent's Hospital
🇺🇸New York, New York, United States
St. Paul Clinic
🇺🇸St. Paul, Minnesota, United States
John Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
St. Luke's Episcopal Hospital/Texas Heart Institute
🇺🇸Houston, Texas, United States
Heart Hospital of New Mexico - NW Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Saint Louis University Hospital
🇺🇸St. Louis, Missouri, United States
Jack D. Weiler Hospital/Albert Einstein Hospital
🇺🇸Bronx, New York, United States
University of Michigan Medical Center, CACR
🇺🇸Ann Arbor, Michigan, United States
University of Ottawa Health Institute
🇨🇦Ottawa, Ontario, Canada
Center Hospital University of Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Cardiology, P.C. Research
🇺🇸Birmingham, Alabama, United States
Cardiovascular Associates/Office of Clinical Research
🇺🇸Birmingham, Alabama, United States
Providence Hospital Heart Failure Clinic
🇺🇸Mobile, Alabama, United States
Central Cardiology Medical Center
🇺🇸Bakersfield, California, United States
Apex Cardiology Consultants, Inc.
🇺🇸Inglewood, California, United States
Arizona Heart Institute
🇺🇸Phoenix, Arizona, United States
Oracle Research-The Heart Center
🇺🇸Huntsville, Alabama, United States
Sarver Heart Center - University of Arizona Health Science
🇺🇸Tucson, Arizona, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Cardiovascular Medical Group & Research Institute
🇺🇸Beverly Hills, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Watson Clinic Center for Research
🇺🇸Lakeland, Florida, United States
Heart & Vascular Institute of Florida
🇺🇸St. Petersburg, Florida, United States
Memorial Health University Medical Center Research Center
🇺🇸Savannah, Georgia, United States
Florida Cardiovascular Institute
🇺🇸Tampa, Florida, United States
Northwestern Memorial Hospital/Heart Failure Program
🇺🇸Chicago, Illinois, United States
Midwest Heart Research Foundation
🇺🇸Lombard, Illinois, United States
Heart Care Midwest
🇺🇸Peoria, Illinois, United States
Gill Heart Institute/University of Kentucky
🇺🇸Lexington, Kentucky, United States
Louisiana Heart Center
🇺🇸Chalmette, Louisiana, United States
University Hospital, Iowa City
🇺🇸Iowa City, Iowa, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
The Creighton Cardiac Center
🇺🇸Omaha, Nebraska, United States
International Heart Institute Montana Foundation
🇺🇸Missoula, Montana, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Beth Israel Medical Center NY/Phillips Ambulatory Care Center
🇺🇸New York, New York, United States
The Toledo Clinic & Outpatient Surgery
🇺🇸Toledo, Ohio, United States
Columbia-Presbyterian Medical Center
🇺🇸New York, New York, United States
Providence Portland Medical Center/Heart Failure Clinic
🇺🇸Portland, Oregon, United States
Oklahoma Foundation-Cardiovascular
🇺🇸Oklahoma City, Oklahoma, United States
The Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Hahnemann University Hospital/HF and Transplant Center
🇺🇸Philadelphia, Pennsylvania, United States
Heart Group
🇺🇸Lancaster, Pennsylvania, United States
Jefferson Heart Institute
🇺🇸Philadelphia, Pennsylvania, United States
Cardiology Associates of West Reading
🇺🇸West Reading, Pennsylvania, United States
Rhode Island Hospital/University Cardiology
🇺🇸Providence, Rhode Island, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Baptist Clinical Research Center
🇺🇸Memphis, Tennessee, United States
Austin-Cardiovascular Associates
🇺🇸Austin, Texas, United States
Buxmont Cardiology Associates
🇺🇸Sellersville, Pennsylvania, United States
Cardiology Group, P.C.
🇺🇸Tullahoma, Tennessee, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
UTHCT/Center for Clinical Research
🇺🇸Tyler, Texas, United States
Heart Specialists
🇺🇸Nassau Bay, Texas, United States
Cardiopulmonary Research Science & Technology Institute
🇺🇸Dallas, Texas, United States
Cardiovascular Research Institute of Dallas
🇺🇸Dallas, Texas, United States
DUCCS Research of South Boston
🇺🇸South Boston, Virginia, United States
Beloit Clinic, SC
🇺🇸Beloit, Wisconsin, United States
Carilion Department of Clinical Research
🇺🇸Roanoke, Virginia, United States
Inland Cardiology Associates
🇺🇸Spokane, Washington, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Southwest Washington Medical Center
🇺🇸Vancouver, Washington, United States
Concord Hospital - Heart Failure Clinic/Department of Cardiology
🇦🇺Concord, New South Wales, Australia
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Canberra Hospital/Cardiology Department
🇦🇺Garran, Australian Capital Territory, Australia
Royal North Shore Hospital - Cardiology Department
🇦🇺St. Leonards, New South Wales, Australia
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Flinders Medical Centre - Cardiac Research Department
🇦🇺Bedford Park, South Australia, Australia
Queen Elizabeth Hospital/Cardiology Department
🇦🇺Woodville, South Australia, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
St. George Hospital/Cardiology Department
🇦🇺Sydney, New South Wales, Australia
Royal Brisbane Hospital - Cardiology Department
🇦🇺Herston, Queensland, Australia
The Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Level 2, Cardiology Department/Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Launceston General Hospital/Cardiac Research Unit
🇦🇺Launceston, Tasmania, Australia
Karinia House/Geelong Hospital
🇦🇺Geelong, Victoria, Australia
Heart Research Institute/Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Neureka Research, Willet Green Niller Centre
🇨🇦Sudbury, Ontario, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
Assaf Harofe Medical Center
🇮🇱Zrifin, Israel
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Heart Institute, Hadassah MC
🇮🇱Jerusalem, Israel
EMMS Nazareth Hospital
🇮🇱Nazareth, Israel
Wolfson Medical Center
🇮🇱Holon, Israel
University of Maryland Hospital
🇺🇸Baltimore, Maryland, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Michigan Heart P.C.
🇺🇸Ypsilanti, Michigan, United States
Hillsboro Cardiology, PC
🇺🇸Hillsboro, Oregon, United States
Sieff Medical Center
🇮🇱Zefat, Israel
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Alberta Hospitals
🇨🇦Edmonton, Alberta, Canada
Christiana Care Health System
🇺🇸Newark, Delaware, United States
New Orleans Clinical Trial Management, Inc.
🇺🇸Covington, Louisiana, United States
Nisus Research/Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
St. Vincent's Hospital - Cardiology Investigational Unit
🇦🇺Fitzroy, Victoria, Australia
Kaplan Medical Center
🇮🇱Rehovot, Israel
Alegent Health Heart and Vascular Institute
🇺🇸Omaha, Nebraska, United States
University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Rockyview Hospital, Heart Health Institute
🇨🇦Calgary, Alberta, Canada
Cardiac Centers of Louisiana, LLC
🇺🇸Shreveport, Louisiana, United States
Heart Failure & Transplantation Program
🇺🇸Newark, New Jersey, United States
Box Hill Hospital - Coronary Care Unit
🇦🇺Box Hill, Victoria, Australia
Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States
Yale University School of Medicine/Heart Failure Center
🇺🇸New Haven, Connecticut, United States
Hospital of Saint Raphael
🇺🇸New Haven, Connecticut, United States
Jacksonville Heart Center PA-Baptist Office
🇺🇸Jacksonville, Florida, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States