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

December 14, 2006 updated by: Abbott

Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Scott Krause, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

October 31, 2002

First Submitted That Met QC Criteria

November 1, 2002

First Posted (Estimate)

November 4, 2002

Study Record Updates

Last Update Posted (Estimate)

December 15, 2006

Last Update Submitted That Met QC Criteria

December 14, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3001069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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