Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.
1 other identifier
interventional
600
4 countries
166
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2002
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 31, 2002
CompletedFirst Posted
Study publicly available on registry
November 4, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedDecember 15, 2006
December 1, 2006
October 31, 2002
December 14, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
- Orion Corporation, Orion Pharmacollaborator
Study Sites (166)
Cardiovascular Associates/Office of Clinical Research
Birmingham, Alabama, 35209, United States
Cardiology, P.C. Research
Birmingham, Alabama, 35211, United States
University Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Oracle Research-The Heart Center
Huntsville, Alabama, 35801, United States
Providence Hospital Heart Failure Clinic
Mobile, Alabama, 36685, United States
Arizona Heart Institute
Phoenix, Arizona, 85006, United States
Sarver Heart Center - University of Arizona Health Science
Tucson, Arizona, 85724, United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Central Cardiology Medical Center
Bakersfield, California, 93301, United States
Cardiovascular Medical Group & Research Institute
Beverly Hills, California, 90210, United States
San Diego Cardiovascular Research
Encinitas, California, 92024, United States
Apex Cardiology Consultants, Inc.
Inglewood, California, 90301, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Los Angeles County/USC Medical Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
Merced Heart Associates
Merced, California, 95340, United States
A.R.I. Clinical Trials, Inc.
Redondo Beach, California, 90277, United States
Sacramento Heart and Vascular Research Center
Sacramento, California, 95825, United States
UCSD Medical Center, University of California
San Diego, California, 92103, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
VA Hospital of San Francisco
San Francisco, California, 94121, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Yale University School of Medicine/Heart Failure Center
New Haven, Connecticut, 06510, United States
Hospital of Saint Raphael
New Haven, Connecticut, 06511, United States
Christiana Care Health System
Newark, Delaware, 19718, United States
Washington Hospital Center - Cardiac Surgery Department
Washington D.C., District of Columbia, 20010, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
University of Florida
Gainesville, Florida, 32610, United States
Jacksonville Heart Center PA-Baptist Office
Jacksonville, Florida, 32207, United States
Jacksonville Heart Center,PA
Jacksonville, Florida, 32250, United States
Watson Clinic Center for Research
Lakeland, Florida, 33805, United States
MIMA Century Research Associates
Melbourne, Florida, 32901, United States
Jackson Memorial Hospital
Miami, Florida, 33102, United States
Miami Research & Education Foundation
Miami, Florida, 33156, United States
The Ford Research Institute PA/NW Florida Heart Group PA
Pensacola, Florida, 32514, United States
Victor Howard M.D., P.A. Heart Research Center
Port Charlotte, Florida, 33952, United States
Heart & Vascular Institute of Florida
St. Petersburg, Florida, 33701, United States
Florida Cardiovascular Institute
Tampa, Florida, 33609, United States
Augusta Cardiology Clinic, P.C.
Augusta, Georgia, 30901, United States
Memorial Health University Medical Center Research Center
Savannah, Georgia, 31405, United States
Northwestern Memorial Hospital/Heart Failure Program
Chicago, Illinois, 60611, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Elgin Cardiology Associates
Elgin, Illinois, 60120, United States
Midwest Heart Research Foundation
Lombard, Illinois, 60148, United States
Heart Care Midwest
Peoria, Illinois, 61603, United States
Clarian Health - Methodist Research Institute Inc.
Indianapolis, Indiana, 46202, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
University Hospital, Iowa City
Iowa City, Iowa, 52242, United States
Via Christi Research Inc. dba PriVia
Wichita, Kansas, 67214, United States
Gill Heart Institute/University of Kentucky
Lexington, Kentucky, 40536, United States
Louisiana Heart Center
Chalmette, Louisiana, 70043, United States
New Orleans Clinical Trial Management, Inc.
Covington, Louisiana, 70433, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Cardiac Centers of Louisiana, LLC
Shreveport, Louisiana, 71135, United States
Medical Research Institute
Slidell, Louisiana, 70458, United States
University of Maryland Hospital
Baltimore, Maryland, 21201, United States
John Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan Medical Center, CACR
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Nisus Research/Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Michigan Heart P.C.
Ypsilanti, Michigan, 48197, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55414, United States
VA Medical Center - Cardiology Department
Minneapolis, Minnesota, 55417, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
St. Paul Clinic
Saint Paul, Minnesota, 55102, United States
University Hospitals Clinic
Columbus, Missouri, 65212, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
International Heart Institute Montana Foundation
Missoula, Montana, 59802, United States
Alegent Health Heart and Vascular Institute
Omaha, Nebraska, 68122, United States
The Creighton Cardiac Center
Omaha, Nebraska, 68131, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Heart Failure & Transplantation Program
Newark, New Jersey, 07112, United States
Heart Hospital of New Mexico - NW Heart Institute
Albuquerque, New Mexico, 87106, United States
Beth Israel Medical Center NY/Phillips Ambulatory Care Center
New York, New York, 10003, United States
St. Vincent's Hospital
New York, New York, 10011, United States
Columbia-Presbyterian Medical Center
New York, New York, 10032, United States
Jack D. Weiler Hospital/Albert Einstein Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center/Cardiology Department
The Bronx, New York, 10467, United States
University Of North Carolina
Chapel Hill, North Carolina, 27599, United States
The Lindner Center
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation/Department of Cardiology
Cleveland, Ohio, 44195, United States
OSU Medical Center-Center Wellness & Prevention
Columbus, Ohio, 43210, United States
The Toledo Clinic & Outpatient Surgery
Toledo, Ohio, 43623, United States
Toledo Clinic & Outpatient Surgery/Department of Cardiology
Toledo, Ohio, 43623, United States
Oklahoma Foundation-Cardiovascular
Oklahoma City, Oklahoma, 73104, United States
University Health Science Center/Cardio Section
Oklahoma City, Oklahoma, 73104, United States
Hillsboro Cardiology, PC
Hillsboro, Oregon, 97123, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Providence Portland Medical Center/Heart Failure Clinic
Portland, Oregon, 97213, United States
Geisinger Health System
Danville, Pennsylvania, 17822, United States
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Heart Group
Lancaster, Pennsylvania, 17603, United States
Hahnemann University Hospital/HF and Transplant Center
Philadelphia, Pennsylvania, 19102, United States
Universtiy of PA Health System
Philadelphia, Pennsylvania, 19104, United States
Jefferson Heart Institute
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Buxmont Cardiology Associates
Sellersville, Pennsylvania, 18960, United States
Cardiology Associates of West Reading
West Reading, Pennsylvania, 19611, United States
Rhode Island Hospital/University Cardiology
Providence, Rhode Island, 02905, United States
Baptist Clinical Research Center
Memphis, Tennessee, 38120, United States
Cardiology Group, P.C.
Tullahoma, Tennessee, 37388, United States
Austin-Cardiovascular Associates
Austin, Texas, 78705, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Cardiopulmonary Research Science & Technology Institute
Dallas, Texas, 75230, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston VA Medical Center
Houston, Texas, 77030, United States
St. Luke's Episcopal Hospital/Texas Heart Institute
Houston, Texas, 77030, United States
Heart Specialists
Nassau Bay, Texas, 77058, United States
University of Texas Health Sciences
San Antonio, Texas, 78229, United States
UTHCT/Center for Clinical Research
Tyler, Texas, 75708, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Carilion Department of Clinical Research
Roanoke, Virginia, 24011, United States
DUCCS Research of South Boston
South Boston, Virginia, 24592, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
University of Washington
Seattle, Washington, 98195, United States
Inland Cardiology Associates
Spokane, Washington, 99204, United States
Southwest Washington Medical Center
Vancouver, Washington, 98664, United States
Beloit Clinic, SC
Beloit, Wisconsin, 53511, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Canberra Hospital/Cardiology Department
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital/Department of Cardiology
Camperdown, New South Wales, 2050, Australia
Concord Hospital - Heart Failure Clinic/Department of Cardiology
Concord, New South Wales, NSW 2139, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Liverpool Hospital - Cardiology Research
Liverpool, New South Wales, 2116, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital - Cardiology Department
St Leonards, New South Wales, Australia
St. George Hospital/Cardiology Department
Sydney, New South Wales, Australia
Royal Brisbane Hospital - Cardiology Department
Herston, Queensland, QLD 4029, Australia
The Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre - Cardiac Research Department
Bedford Park, South Australia, Australia
Queen Elizabeth Hospital/Cardiology Department
Woodville, South Australia, 5011, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Launceston General Hospital/Cardiac Research Unit
Launceston, Tasmania, 7250, Australia
Box Hill Hospital - Coronary Care Unit
Box Hill, Victoria, Australia
St. Vincent's Hospital - Cardiology Investigational Unit
Fitzroy, Victoria, Australia
Karinia House/Geelong Hospital
Geelong, Victoria, 3220, Australia
Level 2, Cardiology Department/Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Heart Research Institute/Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
Rockyview Hospital, Heart Health Institute
Calgary, Alberta, T2V 1P9, Canada
University of Alberta Hospitals
Edmonton, Alberta, T6G 2R7, Canada
Neureka Research, Willet Green Niller Centre
Greater Sudbury, Ontario, P3E 6B4, Canada
University of Ottawa Health Institute
Ottawa, Ontario, K1Y 4W7, Canada
Center Hospital University of Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 3R2, Canada
Barzilai Medical Center
Ashkelon, 78306, Israel
Hillel Yaffe Medical Center
Hadera, 38100, Israel
Wolfson Medical Center
Holon, 58100, Israel
Heart Institute, Hadassah MC
Jerusalem, 91120, Israel
EMMS Nazareth Hospital
Nazareth, 16100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Sieff Medical Center
Safed, 13100, Israel
Assaf Harofe Medical Center
Zrifin, 70300, Israel
Related Publications (1)
Packer M, Colucci W, Fisher L, Massie BM, Teerlink JR, Young J, Padley RJ, Thakkar R, Delgado-Herrera L, Salon J, Garratt C, Huang B, Sarapohja T; REVIVE Heart Failure Study Group. Effect of levosimendan on the short-term clinical course of patients with acutely decompensated heart failure. JACC Heart Fail. 2013 Apr;1(2):103-11. doi: 10.1016/j.jchf.2012.12.004. Epub 2013 Apr 1.
PMID: 24621834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott Krause
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 31, 2002
First Posted
November 4, 2002
Study Start
September 1, 2002
Study Completion
December 1, 2004
Last Updated
December 15, 2006
Record last verified: 2006-12