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

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levosimendan
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Decompensated chronic heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiovascular Associates/Office of Clinical Research
  • Cardiology, P.C. Research
  • University Alabama at Birmingham
  • Oracle Research-The Heart Center
  • Providence Hospital Heart Failure Clinic
  • Arizona Heart Institute
  • Sarver Heart Center - University of Arizona Health Science
  • Central Arkansas Veterans Healthcare System
  • University of Arkansas for Medical Sciences
  • Central Cardiology Medical Center
  • Cardiovascular Medical Group & Research Institute
  • San Diego Cardiovascular Research
  • Apex Cardiology Consultants, Inc.
  • Loma Linda University Medical Center
  • Los Angeles County/USC Medical Center
  • Cedars-Sinai Medical Center
  • VA Greater Los Angeles Healthcare System
  • Merced Heart Associates
  • A.R.I. Clinical Trials, Inc.
  • Sacramento Heart and Vascular Research Center
  • UCSD Medical Center, University of California
  • San Diego Cardiac Center
  • VA San Diego Healthcare System
  • VA Hospital of San Francisco
  • Denver Health Medical Center
  • University of Connecticut Health Center
  • Yale University School of Medicine/Heart Failure Center
  • Hospital of Saint Raphael
  • Christiana Care Health System
  • Washington Hospital Center - Cardiac Surgery Department
  • George Washington University
  • University of Florida
  • Jacksonville Heart Center PA-Baptist Office
  • Jacksonville Heart Center,PA
  • Watson Clinic Center for Research
  • MIMA Century Research Associates
  • Jackson Memorial Hospital
  • Miami Research & Education Foundation
  • The Ford Research Institute PA/NW Florida Heart Group PA
  • Victor Howard M.D., P.A. Heart Research Center
  • Heart & Vascular Institute of Florida
  • Florida Cardiovascular Institute
  • Augusta Cardiology Clinic, P.C.
  • Memorial Health University Medical Center Research Center
  • Northwestern Memorial Hospital/Heart Failure Program
  • Rush-Presbyterian-St. Luke's Medical Center
  • Elgin Cardiology Associates
  • Midwest Heart Research Foundation
  • Heart Care Midwest
  • Clarian Health - Methodist Research Institute Inc.
  • Iowa Heart Center
  • University Hospital, Iowa City
  • Via Christi Research Inc. dba PriVia
  • Gill Heart Institute/University of Kentucky
  • Louisiana Heart Center
  • New Orleans Clinical Trial Management, Inc.
  • Tulane University Health Sciences Center
  • Cardiac Centers of Louisiana, LLC
  • Medical Research Institute
  • University of Maryland Hospital
  • John Hopkins Bayview Medical Center
  • The Johns Hopkins Hospital
  • Boston Medical Center
  • Baystate Medical Center
  • University of Michigan Medical Center, CACR
  • Wayne State University
  • Henry Ford Health System
  • Nisus Research/Northern Michigan Hospital
  • William Beaumont Hospital
  • Michigan Heart P.C.
  • Hennepin County Medical Center
  • VA Medical Center - Cardiology Department
  • University of Minnesota
  • St. Paul Clinic
  • University Hospitals Clinic
  • Saint Louis University Hospital
  • International Heart Institute Montana Foundation
  • Alegent Health Heart and Vascular Institute
  • The Creighton Cardiac Center
  • Dartmouth-Hitchcock Medical Center
  • Hackensack University Medical Center
  • Heart Failure & Transplantation Program
  • Heart Hospital of New Mexico - NW Heart Institute
  • Jack D. Weiler Hospital/Albert Einstein Hospital
  • Montefiore Medical Center/Cardiology Department
  • Beth Israel Medical Center NY/Phillips Ambulatory Care Center
  • St. Vincent's Hospital
  • Columbia-Presbyterian Medical Center
  • University Of North Carolina
  • The Lindner Center
  • University of Cincinnati Medical Center
  • University Hospitals of Cleveland
  • Cleveland Clinic Foundation/Department of Cardiology
  • OSU Medical Center-Center Wellness & Prevention
  • The Toledo Clinic & Outpatient Surgery
  • Toledo Clinic & Outpatient Surgery/Department of Cardiology
  • Oklahoma Foundation-Cardiovascular
  • University Health Science Center/Cardio Section
  • Hillsboro Cardiology, PC
  • Oregon Health & Science University
  • Providence Portland Medical Center/Heart Failure Clinic
  • Geisinger Health System
  • The Milton S. Hershey Medical Center
  • Heart Group
  • Hahnemann University Hospital/HF and Transplant Center
  • Universtiy of PA Health System
  • Jefferson Heart Institute
  • University of Pittsburgh
  • Buxmont Cardiology Associates
  • Cardiology Associates of West Reading
  • Rhode Island Hospital/University Cardiology
  • Baptist Clinical Research Center
  • Cardiology Group, P.C.
  • Austin-Cardiovascular Associates
  • Dallas VA Medical Center
  • Cardiopulmonary Research Science & Technology Institute
  • Cardiovascular Research Institute of Dallas
  • Baylor College of Medicine
  • Houston VA Medical Center
  • St. Luke's Episcopal Hospital/Texas Heart Institute
  • Heart Specialists
  • University of Texas Health Sciences
  • UTHCT/Center for Clinical Research
  • Sentara Norfolk General Hospital
  • Carilion Department of Clinical Research
  • DUCCS Research of South Boston
  • Overlake Hospital Medical Center
  • University of Washington
  • Inland Cardiology Associates
  • Southwest Washington Medical Center
  • Beloit Clinic, SC
  • St. Luke's Medical Center
  • Canberra Hospital/Cardiology Department
  • Royal Prince Alfred Hospital/Department of Cardiology
  • Concord Hospital - Heart Failure Clinic/Department of Cardiology
  • Gosford Hospital
  • Liverpool Hospital - Cardiology Research
  • Prince of Wales Hospital
  • Royal North Shore Hospital - Cardiology Department
  • St. George Hospital/Cardiology Department
  • Royal Brisbane Hospital - Cardiology Department
  • The Princess Alexandra Hospital
  • Flinders Medical Centre - Cardiac Research Department
  • Queen Elizabeth Hospital/Cardiology Department
  • Royal Hobart Hospital
  • Launceston General Hospital/Cardiac Research Unit
  • Box Hill Hospital - Coronary Care Unit
  • St. Vincent's Hospital - Cardiology Investigational Unit
  • Karinia House/Geelong Hospital
  • Level 2, Cardiology Department/Royal Melbourne Hospital
  • Heart Research Institute/Sir Charles Gairdner Hospital
  • University of Calgary
  • Rockyview Hospital, Heart Health Institute
  • University of Alberta Hospitals
  • University of Ottawa Health Institute
  • Neureka Research, Willet Green Niller Centre
  • Center Hospital University of Sherbrooke
  • University of Saskatchewan
  • Barzilai Medical Center
  • Hillel Yaffe Medical Center
  • Wolfson Medical Center
  • Heart Institute, Hadassah MC
  • EMMS Nazareth Hospital
  • Kaplan Medical Center
  • Sieff Medical Center
  • Assaf Harofe Medical Center

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2002
Last Updated
December 14, 2006
Sponsor
Abbott
Collaborators
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00048425
Brief Title
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

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott
Collaborators
Orion Corporation, Orion Pharma

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Decompensated chronic heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Levosimendan
Primary Outcome Measure Information:
Title
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.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
24621834
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.
Results Reference
derived

Learn more about this trial

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

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