Clinical trial NCT00048425: Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure, Congestive
Keywords: Decompensated chronic heart failure
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2002-11-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates/Office of Clinical Research
state: Alabama
city: Birmingham
country: United States
facility: Cardiology, P.C. Research
state: Alabama
city: Birmingham
country: United States
facility: University Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Oracle Research-The Heart Center
state: Alabama
city: Mobile
country: United States
facility: Providence Hospital Heart Failure Clinic
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Tucson
country: United States
facility: Sarver Heart Center - University of Arizona Health Science
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Bakersfield
country: United States
facility: Central Cardiology Medical Center
state: California
city: Beverly Hills
country: United States
facility: Cardiovascular Medical Group & Research Institute
state: California
city: Encinitas
country: United States
facility: San Diego Cardiovascular Research
state: California
city: Inglewood
country: United States
facility: Apex Cardiology Consultants, Inc.
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles County/USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Merced
country: United States
facility: Merced Heart Associates
state: California
city: Redondo Beach
country: United States
facility: A.R.I. Clinical Trials, Inc.
state: California
city: Sacramento
country: United States
facility: Sacramento Heart and Vascular Research Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center, University of California
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: San Francisco
country: United States
facility: VA Hospital of San Francisco
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine/Heart Failure Center
state: Connecticut
city: New Haven
country: United States
facility: Hospital of Saint Raphael
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center - Cardiac Surgery Department
state: District of Columbia
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Heart Center PA-Baptist Office
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Heart Center,PA
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research
state: Florida
city: Melbourne
country: United States
facility: MIMA Century Research Associates
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Miami Research & Education Foundation
state: Florida
city: Pensacola
country: United States
facility: The Ford Research Institute PA/NW Florida Heart Group PA
state: Florida
city: Port Charlotte
country: United States
facility: Victor Howard M.D., P.A. Heart Research Center
state: Florida
city: St. Petersburg
country: United States
facility: Heart & Vascular Institute of Florida
state: Florida
city: Tampa
country: United States
facility: Florida Cardiovascular Institute
state: Florida
city: Augusta
country: United States
facility: Augusta Cardiology Clinic, P.C.
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center Research Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital/Heart Failure Program
state: Illinois
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Elgin
country: United States
facility: Elgin Cardiology Associates
state: Illinois
city: Lombard
country: United States
facility: Midwest Heart Research Foundation
state: Illinois
city: Peoria
country: United States
facility: Heart Care Midwest
state: Illinois
city: Indianapolis
country: United States
facility: Clarian Health - Methodist Research Institute Inc.
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Iowa City
country: United States
facility: University Hospital, Iowa City
state: Iowa
city: Wichita
country: United States
facility: Via Christi Research Inc. dba PriVia
state: Kansas
city: Lexington
country: United States
facility: Gill Heart Institute/University of Kentucky
state: Kentucky
city: Chalmette
country: United States
facility: Louisiana Heart Center
state: Louisiana
city: Covington
country: United States
facility: New Orleans Clinical Trial Management, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: Cardiac Centers of Louisiana, LLC
state: Louisiana
city: Slidell
country: United States
facility: Medical Research Institute
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Hospital
state: Maryland
city: Baltimore
country: United States
facility: John Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center, CACR
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Petoskey
country: United States
facility: Nisus Research/Northern Michigan Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart P.C.
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: VA Medical Center - Cardiology Department
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Clinic
state: Minnesota
city: Columbus
country: United States
facility: University Hospitals Clinic
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Missoula
country: United States
facility: International Heart Institute Montana Foundation
state: Montana
city: Omaha
country: United States
facility: Alegent Health Heart and Vascular Institute
state: Nebraska
city: Omaha
country: United States
facility: The Creighton Cardiac Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Heart Failure & Transplantation Program
state: New Jersey
city: Albuquerque
country: United States
facility: Heart Hospital of New Mexico - NW Heart Institute
state: New Mexico
city: Bronx
country: United States
facility: Jack D. Weiler Hospital/Albert Einstein Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center/Cardiology Department
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center NY/Phillips Ambulatory Care Center
state: New York
city: New York
country: United States
facility: St. Vincent's Hospital
state: New York
city: New York
country: United States
facility: Columbia-Presbyterian Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation/Department of Cardiology
state: Ohio
city: Columbus
country: United States
facility: OSU Medical Center-Center Wellness & Prevention
state: Ohio
city: Toledo
country: United States
facility: The Toledo Clinic & Outpatient Surgery
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic & Outpatient Surgery/Department of Cardiology
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation-Cardiovascular
state: Oklahoma
city: Oklahoma City
country: United States
facility: University Health Science Center/Cardio Section
state: Oklahoma
city: Hillsboro
country: United States
facility: Hillsboro Cardiology, PC
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center/Heart Failure Clinic
state: Oregon
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Hershey
country: United States
facility: The Milton S. Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Heart Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital/HF and Transplant Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Universtiy of PA Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Heart Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Sellersville
country: United States
facility: Buxmont Cardiology Associates
state: Pennsylvania
city: West Reading
country: United States
facility: Cardiology Associates of West Reading
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital/University Cardiology
state: Rhode Island
city: Memphis
country: United States
facility: Baptist Clinical Research Center
state: Tennessee
city: Tullahoma
country: United States
facility: Cardiology Group, P.C.
state: Tennessee
city: Austin
country: United States
facility: Austin-Cardiovascular Associates
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Dallas
country: United States
facility: Cardiopulmonary Research Science & Technology Institute
state: Texas
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston VA Medical Center
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital/Texas Heart Institute
state: Texas
city: Nassau Bay
country: United States
facility: Heart Specialists
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences
state: Texas
city: Tyler
country: United States
facility: UTHCT/Center for Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Department of Clinical Research
state: Virginia
city: South Boston
country: United States
facility: DUCCS Research of South Boston
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Inland Cardiology Associates
state: Washington
city: Vancouver
country: United States
facility: Southwest Washington Medical Center
state: Washington
city: Beloit
country: United States
facility: Beloit Clinic, SC
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Garran
country: Australia
facility: Canberra Hospital/Cardiology Department
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital/Department of Cardiology
state: New South Wales
city: Concord
country: Australia
facility: Concord Hospital - Heart Failure Clinic/Department of Cardiology
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital - Cardiology Research
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital - Cardiology Department
state: New South Wales
city: Sydney
country: Australia
facility: St. George Hospital/Cardiology Department
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane Hospital - Cardiology Department
state: Queensland
city: Woolloongabba
country: Australia
facility: The Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre - Cardiac Research Department
state: South Australia
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital/Cardiology Department
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Launceston
country: Australia
facility: Launceston General Hospital/Cardiac Research Unit
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital - Coronary Care Unit
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital - Cardiology Investigational Unit
state: Victoria
city: Geelong
country: Australia
facility: Karinia House/Geelong Hospital
state: Victoria
city: Parkville
country: Australia
facility: Level 2, Cardiology Department/Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Heart Research Institute/Sir Charles Gairdner Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Rockyview Hospital, Heart Health Institute
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospitals
state: Alberta
city: Ottawa
country: Canada
facility: University of Ottawa Health Institute
state: Ontario
city: Sudbury
country: Canada
facility: Neureka Research, Willet Green Niller Centre
state: Ontario
city: Sherbrooke
country: Canada
facility: Center Hospital University of Sherbrooke
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Heart Institute, Hadassah MC
city: Nazareth
country: Israel
facility: EMMS Nazareth Hospital
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Zefat
country: Israel
facility: Sieff Medical Center
city: Zrifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Abbott
name: Scott Krause
role: STUDY_DIRECTOR
References:
citation: 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.