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Heart Failure, CongestivePhase 3NCT00048425

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

A Phase 3 study testing Levosimendan in people with Heart Failure, Congestive, run by Abbott at 166 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Levosimendan
How many people
600 participants
Where
166 sitesin 4 countries
Study dates
Sep 2002to Dec 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 15Show fewer
  • 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.

Trial locations and contacts

166 sites in 4 countries.

166 sites in 4 countries

United States132 sites

  • Heart Hospital of New Mexico - NW Heart Institute

    Albuquerque, New Mexico, 87106

  • University of Michigan Medical Center, CACR

    Ann Arbor, Michigan, 48109

  • Augusta Cardiology Clinic, P.C.

    Augusta, Georgia, 30901

  • Austin-Cardiovascular Associates

    Austin, Texas, 78705

  • Central Cardiology Medical Center

    Bakersfield, California, 93301

  • University of Maryland Hospital

    Baltimore, Maryland, 21201

  • John Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Beloit Clinic, SC

    Beloit, Wisconsin, 53511

  • Cardiovascular Medical Group & Research Institute

    Beverly Hills, California, 90210

  • Cardiovascular Associates/Office of Clinical Research

    Birmingham, Alabama, 35209

  • Cardiology, P.C. Research

    Birmingham, Alabama, 35211

  • University Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Louisiana Heart Center

    Chalmette, Louisiana, 70043

  • University Of North Carolina

    Chapel Hill, North Carolina, 27599

  • Northwestern Memorial Hospital/Heart Failure Program

    Chicago, Illinois, 60611

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

    Chicago, Illinois, 60612

  • The Lindner Center

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation/Department of Cardiology

    Cleveland, Ohio, 44195

  • University Hospitals Clinic

    Columbus, Missouri, 65212

  • OSU Medical Center-Center Wellness & Prevention

    Columbus, Ohio, 43210

  • New Orleans Clinical Trial Management, Inc.

    Covington, Louisiana, 70433

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Cardiopulmonary Research Science & Technology Institute

    Dallas, Texas, 75230

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231

  • Geisinger Health System

    Danville, Pennsylvania, 17822

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Elgin Cardiology Associates

    Elgin, Illinois, 60120

  • San Diego Cardiovascular Research

    Encinitas, California, 92024

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • University of Florida

    Gainesville, Florida, 32610

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Hillsboro Cardiology, PC

    Hillsboro, Oregon, 97123

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston VA Medical Center

    Houston, Texas, 77030

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

    Houston, Texas, 77030

  • Oracle Research-The Heart Center

    Huntsville, Alabama, 35801

  • Clarian Health - Methodist Research Institute Inc.

    Indianapolis, Indiana, 46202

  • Apex Cardiology Consultants, Inc.

    Inglewood, California, 90301

  • University Hospital, Iowa City

    Iowa City, Iowa, 52242

  • Jacksonville Heart Center PA-Baptist Office

    Jacksonville, Florida, 32207

  • Jacksonville Heart Center,PA

    Jacksonville, Florida, 32250

  • Watson Clinic Center for Research

    Lakeland, Florida, 33805

  • Heart Group

    Lancaster, Pennsylvania, 17603

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Gill Heart Institute/University of Kentucky

    Lexington, Kentucky, 40536

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Midwest Heart Research Foundation

    Lombard, Illinois, 60148

  • Los Angeles County/USC Medical Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • MIMA Century Research Associates

    Melbourne, Florida, 32901

  • Baptist Clinical Research Center

    Memphis, Tennessee, 38120

  • Merced Heart Associates

    Merced, California, 95340

  • Jackson Memorial Hospital

    Miami, Florida, 33102

  • Miami Research & Education Foundation

    Miami, Florida, 33156

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55414

  • VA Medical Center - Cardiology Department

    Minneapolis, Minnesota, 55417

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • International Heart Institute Montana Foundation

    Missoula, Montana, 59802

  • Providence Hospital Heart Failure Clinic

    Mobile, Alabama, 36685

  • Heart Specialists

    Nassau Bay, Texas, 77058

  • Yale University School of Medicine/Heart Failure Center

    New Haven, Connecticut, 06510

  • Hospital of Saint Raphael

    New Haven, Connecticut, 06511

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Beth Israel Medical Center NY/Phillips Ambulatory Care Center

    New York, New York, 10003

  • St. Vincent's Hospital

    New York, New York, 10011

  • Columbia-Presbyterian Medical Center

    New York, New York, 10032

  • Christiana Care Health System

    Newark, Delaware, 19718

  • Heart Failure & Transplantation Program

    Newark, New Jersey, 07112

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Oklahoma Foundation-Cardiovascular

    Oklahoma City, Oklahoma, 73104

  • University Health Science Center/Cardio Section

    Oklahoma City, Oklahoma, 73104

  • Alegent Health Heart and Vascular Institute

    Omaha, Nebraska, 68122

  • The Creighton Cardiac Center

    Omaha, Nebraska, 68131

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

    Pensacola, Florida, 32514

  • Heart Care Midwest

    Peoria, Illinois, 61603

  • Nisus Research/Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Hahnemann University Hospital/HF and Transplant Center

    Philadelphia, Pennsylvania, 19102

  • Universtiy of PA Health System

    Philadelphia, Pennsylvania, 19104

  • Jefferson Heart Institute

    Philadelphia, Pennsylvania, 19107

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

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

    Port Charlotte, Florida, 33952

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • Providence Portland Medical Center/Heart Failure Clinic

    Portland, Oregon, 97213

  • Rhode Island Hospital/University Cardiology

    Providence, Rhode Island, 02905

  • A.R.I. Clinical Trials, Inc.

    Redondo Beach, California, 90277

  • Carilion Department of Clinical Research

    Roanoke, Virginia, 24011

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Sacramento Heart and Vascular Research Center

    Sacramento, California, 95825

  • St. Paul Clinic

    Saint Paul, Minnesota, 55102

  • University of Texas Health Sciences

    San Antonio, Texas, 78229

  • UCSD Medical Center, University of California

    San Diego, California, 92103

  • San Diego Cardiac Center

    San Diego, California, 92123

  • VA San Diego Healthcare System

    San Diego, California, 92161

  • VA Hospital of San Francisco

    San Francisco, California, 94121

  • Memorial Health University Medical Center Research Center

    Savannah, Georgia, 31405

  • University of Washington

    Seattle, Washington, 98195

  • Buxmont Cardiology Associates

    Sellersville, Pennsylvania, 18960

  • Cardiac Centers of Louisiana, LLC

    Shreveport, Louisiana, 71135

  • Medical Research Institute

    Slidell, Louisiana, 70458

  • DUCCS Research of South Boston

    South Boston, Virginia, 24592

  • Inland Cardiology Associates

    Spokane, Washington, 99204

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Heart & Vascular Institute of Florida

    St. Petersburg, Florida, 33701

  • Florida Cardiovascular Institute

    Tampa, Florida, 33609

  • Jack D. Weiler Hospital/Albert Einstein Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center/Cardiology Department

    The Bronx, New York, 10467

  • The Toledo Clinic & Outpatient Surgery

    Toledo, Ohio, 43623

  • Toledo Clinic & Outpatient Surgery/Department of Cardiology

    Toledo, Ohio, 43623

  • Sarver Heart Center - University of Arizona Health Science

    Tucson, Arizona, 85724

  • Cardiology Group, P.C.

    Tullahoma, Tennessee, 37388

  • UTHCT/Center for Clinical Research

    Tyler, Texas, 75708

  • Southwest Washington Medical Center

    Vancouver, Washington, 98664

  • Washington Hospital Center - Cardiac Surgery Department

    Washington D.C., District of Columbia, 20010

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • Cardiology Associates of West Reading

    West Reading, Pennsylvania, 19611

  • Via Christi Research Inc. dba PriVia

    Wichita, Kansas, 67214

  • Michigan Heart P.C.

    Ypsilanti, Michigan, 48197

Other trials in United States

Australia19 sites

  • Flinders Medical Centre - Cardiac Research Department

    Bedford Park, South Australia

  • Box Hill Hospital - Coronary Care Unit

    Box Hill, Victoria

  • Royal Prince Alfred Hospital/Department of Cardiology

    Camperdown, New South Wales, 2050

  • Concord Hospital - Heart Failure Clinic/Department of Cardiology

    Concord, New South Wales, NSW 2139

  • St. Vincent's Hospital - Cardiology Investigational Unit

    Fitzroy, Victoria

  • Canberra Hospital/Cardiology Department

    Garran, Australian Capital Territory, 2605

  • Karinia House/Geelong Hospital

    Geelong, Victoria, 3220

  • Gosford Hospital

    Gosford, New South Wales

  • Royal Brisbane Hospital - Cardiology Department

    Herston, Queensland, QLD 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Launceston General Hospital/Cardiac Research Unit

    Launceston, Tasmania, 7250

  • Liverpool Hospital - Cardiology Research

    Liverpool, New South Wales, 2116

  • Heart Research Institute/Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Level 2, Cardiology Department/Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Prince of Wales Hospital

    Randwick, New South Wales

  • Royal North Shore Hospital - Cardiology Department

    St Leonards, New South Wales

  • St. George Hospital/Cardiology Department

    Sydney, New South Wales

  • Queen Elizabeth Hospital/Cardiology Department

    Woodville, South Australia, 5011

  • The Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Israel8 sites

  • Barzilai Medical Center

    Ashkelon, 78306

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Wolfson Medical Center

    Holon, 58100

  • Heart Institute, Hadassah MC

    Jerusalem, 91120

  • EMMS Nazareth Hospital

    Nazareth, 16100

  • Kaplan Medical Center

    Rehovot, 76100

  • Sieff Medical Center

    Safed, 13100

  • Assaf Harofe Medical Center

    Zrifin, 70300

Other trials in Israel

Canada7 sites

  • University of Calgary

    Calgary, Alberta, T2N 4N1

  • Rockyview Hospital, Heart Health Institute

    Calgary, Alberta, T2V 1P9

  • University of Alberta Hospitals

    Edmonton, Alberta, T6G 2R7

  • Neureka Research, Willet Green Niller Centre

    Greater Sudbury, Ontario, P3E 6B4

  • University of Ottawa Health Institute

    Ottawa, Ontario, K1Y 4W7

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 3R2

  • Center Hospital University of Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this 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.

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.

Being tested
Levosimendan
Keywords
Decompensated chronic heart failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevosimendanDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2002 (estimated)
  2. Study startSep 2002
  3. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00048425
Sponsor's protocol ID
3001069
Status last verified
Dec 2006
First submitted
31 Oct 2002
Last updated
15 Dec 2006
Results posted
No

Publications

  • 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.

    PubMed 24621834

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levosimendan in people with Heart Failure, Congestive, run by Abbott at 166 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Australia, Israel, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00048425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2006.

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