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

Heart Failure, Congestive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048425
• Other study ID #: 3001069
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2002
• Last updated: December 14, 2006
• Start date: September 2002
• Est. completion date: December 2004

Study information

• Verified date: December 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• Levosimendan

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.