Full Text View
Tabular View
No Study Results Posted
Related Studies
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
This study has been completed.
First Received: October 31, 2002   Last Updated: December 14, 2006   History of Changes
Sponsor: Abbott
Collaborator: Orion Corporation, Orion Pharma
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00048425
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
Drug: Levosimendan
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 600
Study Start Date: September 2002
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048425

  Hide Study Locations
Locations
United States, Alabama
University Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Cardiology, P.C. Research
Birmingham, Alabama, United States, 35211
Cardiovascular Associates/Office of Clinical Research
Birmingham, Alabama, United States, 35209
Providence Hospital Heart Failure Clinic
Mobile, Alabama, United States, 36685
Oracle Research-The Heart Center
Huntsville, Alabama, United States, 35801
United States, Arizona
Sarver Heart Center - University of Arizona Health Science
Tucson, Arizona, United States, 85724
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
United States, Arkansas
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Los Angeles County/USC Medical Center
Los Angeles, California, United States, 90033
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Apex Cardiology Consultants, Inc.
Inglewood, California, United States, 90301
UCSD Medical Center, University of California
San Diego, California, United States, 92103
San Diego Cardiovascular Research
Encinitas, California, United States, 92024
San Diego Cardiac Center
San Diego, California, United States, 92123
Central Cardiology Medical Center
Bakersfield, California, United States, 93301
A.R.I. Clinical Trials, Inc.
Redondo Beach, California, United States, 90277
Cardiovascular Medical Group & Research Institute
Beverly Hills, California, United States, 90210
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sacramento Heart and Vascular Research Center
Sacramento, California, United States, 95825
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
VA Hospital of San Francisco
San Francisco, California, United States, 94121
VA San Diego Healthcare System
San Diego, California, United States, 92161
Merced Heart Associates
Merced, California, United States, 95340
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Yale University School of Medicine/Heart Failure Center
New Haven, Connecticut, United States, 06510
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
Washington Hospital Center - Cardiac Surgery Department
Washington, District of Columbia, United States, 20010
United States, Florida
Heart & Vascular Institute of Florida
St. Petersburg, Florida, United States, 33701
Watson Clinic Center for Research
Lakeland, Florida, United States, 33805
University of Florida
Gainesville, Florida, United States, 32610
Jacksonville Heart Center PA-Baptist Office
Jacksonville, Florida, United States, 32207
MIMA Century Research Associates
Melbourne, Florida, United States, 32901
Jacksonville Heart Center,PA
Jacksonville, Florida, United States, 32250
The Ford Research Institute PA/NW Florida Heart Group PA
Pensacola, Florida, United States, 32514
Florida Cardiovascular Institute
Tampa, Florida, United States, 33609
Victor Howard M.D., P.A. Heart Research Center
Port Charlotte, Florida, United States, 33952
Jackson Memorial Hospital
Miami, Florida, United States, 33102
Miami Research & Education Foundation
Miami, Florida, United States, 33156
United States, Georgia
Memorial Health University Medical Center Research Center
Savannah, Georgia, United States, 31405
Augusta Cardiology Clinic, P.C.
Augusta, Georgia, United States, 30901
United States, Illinois
Northwestern Memorial Hospital/Heart Failure Program
Chicago, Illinois, United States, 60611
Heart Care Midwest
Peoria, Illinois, United States, 61603
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Elgin Cardiology Associates
Elgin, Illinois, United States, 60120
Midwest Heart Research Foundation
Lombard, Illinois, United States, 60148
United States, Indiana
Clarian Health - Methodist Research Institute Inc.
Indianapolis, Indiana, United States, 46202
United States, Iowa
University Hospital, Iowa City
Iowa City, Iowa, United States, 52242
Iowa Heart Center
Des Moines, Iowa, United States, 50314
United States, Kansas
Via Christi Research Inc. dba PriVia
Wichita, Kansas, United States, 67214
United States, Kentucky
Gill Heart Institute/University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Cardiac Centers of Louisiana, LLC
Shreveport, Louisiana, United States, 71135
New Orleans Clinical Trial Management, Inc.
Covington, Louisiana, United States, 70433
Louisiana Heart Center
Chalmette, Louisiana, United States, 70043
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Medical Research Institute
Slidell, Louisiana, United States, 70458
United States, Maryland
University of Maryland Hospital
Baltimore, Maryland, United States, 21201
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Nisus Research/Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
Michigan Heart P.C.
Ypsilanti, Michigan, United States, 48197
Wayne State University
Detroit, Michigan, United States, 48201
University of Michigan Medical Center, CACR
Ann Arbor, Michigan, United States, 48109
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
VA Medical Center - Cardiology Department
Minneapolis, Minnesota, United States, 55417
St. Paul Clinic
St. Paul, Minnesota, United States, 55102
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55414
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Louis University Hospital
St. Louis, Missouri, United States, 63110
University Hospitals Clinic
Columbus, Missouri, United States, 65212
United States, Montana
International Heart Institute Montana Foundation
Missoula, Montana, United States, 59802
United States, Nebraska
Alegent Health Heart and Vascular Institute
Omaha, Nebraska, United States, 68122
The Creighton Cardiac Center
Omaha, Nebraska, United States, 68131
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Heart Failure & Transplantation Program
Newark, New Jersey, United States, 07112
United States, New Mexico
Heart Hospital of New Mexico - NW Heart Institute
Albuquerque, New Mexico, United States, 87106
United States, New York
Columbia-Presbyterian Medical Center
New York, New York, United States, 10032
Beth Israel Medical Center NY/Phillips Ambulatory Care Center
New York, New York, United States, 10003
St. Vincent's Hospital
New York, New York, United States, 10011
Jack D. Weiler Hospital/Albert Einstein Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center/Cardiology Department
Bronx, New York, United States, 10467
United States, North Carolina
University Of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
The Lindner Center
Cincinnati, Ohio, United States, 45219
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Toledo Clinic & Outpatient Surgery/Department of Cardiology
Toledo, Ohio, United States, 43623
OSU Medical Center-Center Wellness & Prevention
Columbus, Ohio, United States, 43210
The Toledo Clinic & Outpatient Surgery
Toledo, Ohio, United States, 43623
Cleveland Clinic Foundation/Department of Cardiology
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University Health Science Center/Cardio Section
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Foundation-Cardiovascular
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
Hillsboro Cardiology, PC
Hillsboro, Oregon, United States, 97123
Providence Portland Medical Center/Heart Failure Clinic
Portland, Oregon, United States, 97213
United States, Pennsylvania
Cardiology Associates of West Reading
West Reading, Pennsylvania, United States, 19611
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Geisinger Health System
Danville, Pennsylvania, United States, 17822
Buxmont Cardiology Associates
Sellersville, Pennsylvania, United States, 18960
Hahnemann University Hospital/HF and Transplant Center
Philadelphia, Pennsylvania, United States, 19102
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Heart Group
Lancaster, Pennsylvania, United States, 17603
Jefferson Heart Institute
Philadelphia, Pennsylvania, United States, 19107
Universtiy of PA Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital/University Cardiology
Providence, Rhode Island, United States, 02905
United States, Tennessee
Cardiology Group, P.C.
Tullahoma, Tennessee, United States, 37388
Baptist Clinical Research Center
Memphis, Tennessee, United States, 38120
United States, Texas
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States, 75231
Heart Specialists
Nassau Bay, Texas, United States, 77058
Houston VA Medical Center
Houston, Texas, United States, 77030
Dallas VA Medical Center
Dallas, Texas, United States, 75216
University of Texas Health Sciences
San Antonio, Texas, United States, 78229
UTHCT/Center for Clinical Research
Tyler, Texas, United States, 75708
Baylor College of Medicine
Houston, Texas, United States, 77030
Austin-Cardiovascular Associates
Austin, Texas, United States, 78705
St. Luke's Episcopal Hospital/Texas Heart Institute
Houston, Texas, United States, 77030
Cardiopulmonary Research Science & Technology Institute
Dallas, Texas, United States, 75230
United States, Virginia
DUCCS Research of South Boston
South Boston, Virginia, United States, 24592
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Carilion Department of Clinical Research
Roanoke, Virginia, United States, 24011
United States, Washington
Inland Cardiology Associates
Spokane, Washington, United States, 99204
University of Washington
Seattle, Washington, United States, 98195
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
Southwest Washington Medical Center
Vancouver, Washington, United States, 98664
United States, Wisconsin
Beloit Clinic, SC
Beloit, Wisconsin, United States, 53511
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Australia, Australian Capital Territory
Canberra Hospital/Cardiology Department
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Concord Hospital - Heart Failure Clinic/Department of Cardiology
Concord, New South Wales, Australia, NSW 2139
Royal North Shore Hospital - Cardiology Department
St. Leonards, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Royal Prince Alfred Hospital/Department of Cardiology
Camperdown, New South Wales, Australia, 2050
St. George Hospital/Cardiology Department
Sydney, New South Wales, Australia
Liverpool Hospital - Cardiology Research
Liverpool, New South Wales, Australia, 2116
Australia, Queensland
Royal Brisbane Hospital - Cardiology Department
Herston, Queensland, Australia, QLD 4029
The Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Centre - Cardiac Research Department
Bedford Park, South Australia, Australia
Queen Elizabeth Hospital/Cardiology Department
Woodville, South Australia, Australia, 5011
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Launceston General Hospital/Cardiac Research Unit
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Box Hill Hospital - Coronary Care Unit
Box Hill, Victoria, Australia
St. Vincent's Hospital - Cardiology Investigational Unit
Fitzroy, Victoria, Australia
Level 2, Cardiology Department/Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Karinia House/Geelong Hospital
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Heart Research Institute/Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Canada, Alberta
University of Alberta Hospitals
Edmonton, Alberta, Canada, T6G 2R7
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Rockyview Hospital, Heart Health Institute
Calgary, Alberta, Canada, T2V 1P9
Canada, Ontario
University of Ottawa Health Institute
Ottawa, Ontario, Canada, K1Y 4W7
Neureka Research, Willet Green Niller Centre
Sudbury, Ontario, Canada, P3E 6B4
Canada, Quebec
Center Hospital University of Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 3R2
Israel
Kaplan Medical Center
Rehovot, Israel, 76100
Heart Institute, Hadassah MC
Jerusalem, Israel, 91120
Sieff Medical Center
Zefat, Israel, 13100
Wolfson Medical Center
Holon, Israel, 58100
Barzilai Medical Center
Ashkelon, Israel, 78306
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Assaf Harofe Medical Center
Zrifin, Israel, 70300
EMMS Nazareth Hospital
Nazareth, Israel, 16100
Sponsors and Collaborators
Abbott
Orion Corporation, Orion Pharma
Investigators
Study Director: Scott Krause Abbott
  More Information

No publications provided

Study ID Numbers: 3001069
Study First Received: October 31, 2002
Last Updated: December 14, 2006
ClinicalTrials.gov Identifier: NCT00048425     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Decompensated chronic heart failure

Additional relevant MeSH terms:
Heart Failure
Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Simendan
Phosphodiesterase Inhibitors
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on November 27, 2009