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

Last updated: December 14, 2006
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Hyponatremia

Congestive Heart Failure

Heart Failure

Treatment

N/A

Clinical Study ID

NCT00048425
3001069
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A written informed consent must be obtained for hospitalized male or female patientsover 18 years old of age.

  • The eligible patients must be diagnosed with worsening heart failure as evidenced bydyspnea 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

Exclusion Criteria: The following criteria would exclude the patient from study:

  • invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiacre-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 useadequate contraceptive precautions.

  • Also excluded is the use of amrinone and milrinone prior to randomization, a historyof hypersensitivity to levosimendan or any of the excipients and previousparticipation in a clinical trial with any experimental treatment within the last 30days.

Study Design

Total Participants: 600
Study Start date:
September 01, 2002
Estimated Completion Date:
December 31, 2004

Connect with a study center

  • Canberra Hospital/Cardiology Department

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital/Department of Cardiology

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Concord Hospital - Heart Failure Clinic/Department of Cardiology

    Concord, New South Wales NSW 2139
    Australia

    Site Not Available

  • Gosford Hospital

    Gosford, New South Wales
    Australia

    Site Not Available

  • Liverpool Hospital - Cardiology Research

    Liverpool, New South Wales 2116
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales
    Australia

    Site Not Available

  • Royal North Shore Hospital - Cardiology Department

    St. Leonards, New South Wales
    Australia

    Site Not Available

  • St. George Hospital/Cardiology Department

    Sydney, New South Wales
    Australia

    Site Not Available

  • Royal Brisbane Hospital - Cardiology Department

    Herston, Queensland QLD 4029
    Australia

    Site Not Available

  • The Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Flinders Medical Centre - Cardiac Research Department

    Bedford Park, South Australia
    Australia

    Site Not Available

  • Queen Elizabeth Hospital/Cardiology Department

    Woodville, South Australia 5011
    Australia

    Site Not Available

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Launceston General Hospital/Cardiac Research Unit

    Launceston, Tasmania 7250
    Australia

    Site Not Available

  • Box Hill Hospital - Coronary Care Unit

    Box Hill, Victoria
    Australia

    Site Not Available

  • St. Vincent's Hospital - Cardiology Investigational Unit

    Fitzroy, Victoria
    Australia

    Site Not Available

  • Karinia House/Geelong Hospital

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Level 2, Cardiology Department/Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Heart Research Institute/Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Rockyview Hospital, Heart Health Institute

    Calgary, Alberta T2V 1P9
    Canada

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • University of Alberta Hospitals

    Edmonton, Alberta T6G 2R7
    Canada

    Site Not Available

  • University of Ottawa Health Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • Neureka Research, Willet Green Niller Centre

    Sudbury, Ontario P3E 6B4
    Canada

    Site Not Available

  • Center Hospital University of Sherbrooke

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • University of Saskatchewan

    Saskatoon, Saskatchewan S7N 3R2
    Canada

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 78306
    Israel

    Site Not Available

  • Hillel Yaffe Medical Center

    Hadera, 38100
    Israel

    Site Not Available

  • Wolfson Medical Center

    Holon, 58100
    Israel

    Site Not Available

  • Heart Institute, Hadassah MC

    Jerusalem, 91120
    Israel

    Site Not Available

  • EMMS Nazareth Hospital

    Nazareth, 16100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot, 76100
    Israel

    Site Not Available

  • Sieff Medical Center

    Zefat, 13100
    Israel

    Site Not Available

  • Assaf Harofe Medical Center

    Zrifin, 70300
    Israel

    Site Not Available

  • Cardiology, P.C. Research

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • Cardiovascular Associates/Office of Clinical Research

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • University Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Oracle Research-The Heart Center

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Providence Hospital Heart Failure Clinic

    Mobile, Alabama 36685
    United States

    Site Not Available

  • Arizona Heart Institute

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Sarver Heart Center - University of Arizona Health Science

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Central Cardiology Medical Center

    Bakersfield, California 93301
    United States

    Site Not Available

  • Cardiovascular Medical Group & Research Institute

    Beverly Hills, California 90210
    United States

    Site Not Available

  • San Diego Cardiovascular Research

    Encinitas, California 92024
    United States

    Site Not Available

  • Apex Cardiology Consultants, Inc.

    Inglewood, California 90301
    United States

    Site Not Available

  • Loma Linda University Medical Center

    Loma Linda, California 92354
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Los Angeles County/USC Medical Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California 90073
    United States

    Site Not Available

  • Merced Heart Associates

    Merced, California 95340
    United States

    Site Not Available

  • A.R.I. Clinical Trials, Inc.

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Sacramento Heart and Vascular Research Center

    Sacramento, California 95825
    United States

    Site Not Available

  • San Diego Cardiac Center

    San Diego, California 92123
    United States

    Site Not Available

  • UCSD Medical Center, University of California

    San Diego, California 92103
    United States

    Site Not Available

  • VA San Diego Healthcare System

    San Diego, California 92161
    United States

    Site Not Available

  • VA Hospital of San Francisco

    San Francisco, California 94121
    United States

    Site Not Available

  • Denver Health Medical Center

    Denver, Colorado 80204
    United States

    Site Not Available

  • University of Connecticut Health Center

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Hospital of Saint Raphael

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Yale University School of Medicine/Heart Failure Center

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Christiana Care Health System

    Newark, Delaware 19718
    United States

    Site Not Available

  • George Washington University

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Washington Hospital Center - Cardiac Surgery Department

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Jacksonville Heart Center PA-Baptist Office

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Jacksonville Heart Center,PA

    Jacksonville, Florida 32250
    United States

    Site Not Available

  • Watson Clinic Center for Research

    Lakeland, Florida 33805
    United States

    Site Not Available

  • MIMA Century Research Associates

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Jackson Memorial Hospital

    Miami, Florida 33102
    United States

    Site Not Available

  • Miami Research & Education Foundation

    Miami, Florida 33156
    United States

    Site Not Available

  • The Ford Research Institute PA/NW Florida Heart Group PA

    Pensacola, Florida 32514
    United States

    Site Not Available

  • Victor Howard M.D., P.A. Heart Research Center

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Heart & Vascular Institute of Florida

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Florida Cardiovascular Institute

    Tampa, Florida 33609
    United States

    Site Not Available

  • Augusta Cardiology Clinic, P.C.

    Augusta, Georgia 30901
    United States

    Site Not Available

  • Memorial Health University Medical Center Research Center

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Northwestern Memorial Hospital/Heart Failure Program

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Elgin Cardiology Associates

    Elgin, Illinois 60120
    United States

    Site Not Available

  • Midwest Heart Research Foundation

    Lombard, Illinois 60148
    United States

    Site Not Available

  • Heart Care Midwest

    Peoria, Illinois 61603
    United States

    Site Not Available

  • Clarian Health - Methodist Research Institute Inc.

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Iowa Heart Center

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • University Hospital, Iowa City

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Via Christi Research Inc. dba PriVia

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Gill Heart Institute/University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Louisiana Heart Center

    Chalmette, Louisiana 70043
    United States

    Site Not Available

  • New Orleans Clinical Trial Management, Inc.

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Tulane University Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Cardiac Centers of Louisiana, LLC

    Shreveport, Louisiana 71135
    United States

    Site Not Available

  • Medical Research Institute

    Slidell, Louisiana 70458
    United States

    Site Not Available

  • John Hopkins Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • The Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Maryland Hospital

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • University of Michigan Medical Center, CACR

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Nisus Research/Northern Michigan Hospital

    Petoskey, Michigan 49770
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Michigan Heart P.C.

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55414
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • VA Medical Center - Cardiology Department

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • St. Paul Clinic

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • University Hospitals Clinic

    Columbus, Missouri 65212
    United States

    Site Not Available

  • Saint Louis University Hospital

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • International Heart Institute Montana Foundation

    Missoula, Montana 59802
    United States

    Site Not Available

  • Alegent Health Heart and Vascular Institute

    Omaha, Nebraska 68122
    United States

    Site Not Available

  • The Creighton Cardiac Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Heart Failure & Transplantation Program

    Newark, New Jersey 07112
    United States

    Site Not Available

  • Heart Hospital of New Mexico - NW Heart Institute

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Jack D. Weiler Hospital/Albert Einstein Hospital

    Bronx, New York 10461
    United States

    Site Not Available

  • Montefiore Medical Center/Cardiology Department

    Bronx, New York 10467
    United States

    Site Not Available

  • Beth Israel Medical Center NY/Phillips Ambulatory Care Center

    New York, New York 10003
    United States

    Site Not Available

  • Columbia-Presbyterian Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • St. Vincent's Hospital

    New York, New York 10011
    United States

    Site Not Available

  • University Of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • The Lindner Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Foundation/Department of Cardiology

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • OSU Medical Center-Center Wellness & Prevention

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Toledo Clinic & Outpatient Surgery

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Toledo Clinic & Outpatient Surgery/Department of Cardiology

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Oklahoma Foundation-Cardiovascular

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University Health Science Center/Cardio Section

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Hillsboro Cardiology, PC

    Hillsboro, Oregon 97123
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97201
    United States

    Site Not Available

  • Providence Portland Medical Center/Heart Failure Clinic

    Portland, Oregon 97213
    United States

    Site Not Available

  • Geisinger Health System

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • The Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Heart Group

    Lancaster, Pennsylvania 17603
    United States

    Site Not Available

  • Hahnemann University Hospital/HF and Transplant Center

    Philadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • Jefferson Heart Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Universtiy of PA Health System

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Buxmont Cardiology Associates

    Sellersville, Pennsylvania 18960
    United States

    Site Not Available

  • Cardiology Associates of West Reading

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Rhode Island Hospital/University Cardiology

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Baptist Clinical Research Center

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Cardiology Group, P.C.

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • Austin-Cardiovascular Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Cardiopulmonary Research Science & Technology Institute

    Dallas, Texas 75230
    United States

    Site Not Available

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Dallas VA Medical Center

    Dallas, Texas 75216
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston VA Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • St. Luke's Episcopal Hospital/Texas Heart Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • Heart Specialists

    Nassau Bay, Texas 77058
    United States

    Site Not Available

  • University of Texas Health Sciences

    San Antonio, Texas 78229
    United States

    Site Not Available

  • UTHCT/Center for Clinical Research

    Tyler, Texas 75708
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Carilion Department of Clinical Research

    Roanoke, Virginia 24011
    United States

    Site Not Available

  • DUCCS Research of South Boston

    South Boston, Virginia 24592
    United States

    Site Not Available

  • Overlake Hospital Medical Center

    Bellevue, Washington 98004
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • Inland Cardiology Associates

    Spokane, Washington 99204
    United States

    Site Not Available

  • Southwest Washington Medical Center

    Vancouver, Washington 98664
    United States

    Site Not Available

  • Beloit Clinic, SC

    Beloit, Wisconsin 53511
    United States

    Site Not Available

  • St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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