Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00048425
Collaborator
Orion Corporation, Orion Pharma (Industry)
600
166
27
3.6
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Sep 1, 2002
Study Completion Date
:
Dec 1, 2004
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiovascular Associates/Office of Clinical Research | Birmingham | Alabama | United States | 35209 |
| 2 | Cardiology, P.C. Research | Birmingham | Alabama | United States | 35211 |
| 3 | University Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 4 | Oracle Research-The Heart Center | Huntsville | Alabama | United States | 35801 |
| 5 | Providence Hospital Heart Failure Clinic | Mobile | Alabama | United States | 36685 |
| 6 | Arizona Heart Institute | Phoenix | Arizona | United States | 85006 |
| 7 | Sarver Heart Center - University of Arizona Health Science | Tucson | Arizona | United States | 85724 |
| 8 | Central Arkansas Veterans Healthcare System | Little Rock | Arkansas | United States | 72205 |
| 9 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 10 | Central Cardiology Medical Center | Bakersfield | California | United States | 93301 |
| 11 | Cardiovascular Medical Group & Research Institute | Beverly Hills | California | United States | 90210 |
| 12 | San Diego Cardiovascular Research | Encinitas | California | United States | 92024 |
| 13 | Apex Cardiology Consultants, Inc. | Inglewood | California | United States | 90301 |
| 14 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 15 | Los Angeles County/USC Medical Center | Los Angeles | California | United States | 90033 |
| 16 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 17 | VA Greater Los Angeles Healthcare System | Los Angeles | California | United States | 90073 |
| 18 | Merced Heart Associates | Merced | California | United States | 95340 |
| 19 | A.R.I. Clinical Trials, Inc. | Redondo Beach | California | United States | 90277 |
| 20 | Sacramento Heart and Vascular Research Center | Sacramento | California | United States | 95825 |
| 21 | UCSD Medical Center, University of California | San Diego | California | United States | 92103 |
| 22 | San Diego Cardiac Center | San Diego | California | United States | 92123 |
| 23 | VA San Diego Healthcare System | San Diego | California | United States | 92161 |
| 24 | VA Hospital of San Francisco | San Francisco | California | United States | 94121 |
| 25 | Denver Health Medical Center | Denver | Colorado | United States | 80204 |
| 26 | University of Connecticut Health Center | Farmington | Connecticut | United States | 06030 |
| 27 | Yale University School of Medicine/Heart Failure Center | New Haven | Connecticut | United States | 06510 |
| 28 | Hospital of Saint Raphael | New Haven | Connecticut | United States | 06511 |
| 29 | Christiana Care Health System | Newark | Delaware | United States | 19718 |
| 30 | Washington Hospital Center - Cardiac Surgery Department | Washington | District of Columbia | United States | 20010 |
| 31 | George Washington University | Washington | District of Columbia | United States | 20037 |
| 32 | University of Florida | Gainesville | Florida | United States | 32610 |
| 33 | Jacksonville Heart Center PA-Baptist Office | Jacksonville | Florida | United States | 32207 |
| 34 | Jacksonville Heart Center,PA | Jacksonville | Florida | United States | 32250 |
| 35 | Watson Clinic Center for Research | Lakeland | Florida | United States | 33805 |
| 36 | MIMA Century Research Associates | Melbourne | Florida | United States | 32901 |
| 37 | Jackson Memorial Hospital | Miami | Florida | United States | 33102 |
| 38 | Miami Research & Education Foundation | Miami | Florida | United States | 33156 |
| 39 | The Ford Research Institute PA/NW Florida Heart Group PA | Pensacola | Florida | United States | 32514 |
| 40 | Victor Howard M.D., P.A. Heart Research Center | Port Charlotte | Florida | United States | 33952 |
| 41 | Heart & Vascular Institute of Florida | St. Petersburg | Florida | United States | 33701 |
| 42 | Florida Cardiovascular Institute | Tampa | Florida | United States | 33609 |
| 43 | Augusta Cardiology Clinic, P.C. | Augusta | Georgia | United States | 30901 |
| 44 | Memorial Health University Medical Center Research Center | Savannah | Georgia | United States | 31405 |
| 45 | Northwestern Memorial Hospital/Heart Failure Program | Chicago | Illinois | United States | 60611 |
| 46 | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | United States | 60612 |
| 47 | Elgin Cardiology Associates | Elgin | Illinois | United States | 60120 |
| 48 | Midwest Heart Research Foundation | Lombard | Illinois | United States | 60148 |
| 49 | Heart Care Midwest | Peoria | Illinois | United States | 61603 |
| 50 | Clarian Health - Methodist Research Institute Inc. | Indianapolis | Indiana | United States | 46202 |
| 51 | Iowa Heart Center | Des Moines | Iowa | United States | 50314 |
| 52 | University Hospital, Iowa City | Iowa City | Iowa | United States | 52242 |
| 53 | Via Christi Research Inc. dba PriVia | Wichita | Kansas | United States | 67214 |
| 54 | Gill Heart Institute/University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 55 | Louisiana Heart Center | Chalmette | Louisiana | United States | 70043 |
| 56 | New Orleans Clinical Trial Management, Inc. | Covington | Louisiana | United States | 70433 |
| 57 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 58 | Cardiac Centers of Louisiana, LLC | Shreveport | Louisiana | United States | 71135 |
| 59 | Medical Research Institute | Slidell | Louisiana | United States | 70458 |
| 60 | University of Maryland Hospital | Baltimore | Maryland | United States | 21201 |
| 61 | John Hopkins Bayview Medical Center | Baltimore | Maryland | United States | 21224 |
| 62 | The Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
| 63 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 64 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
| 65 | University of Michigan Medical Center, CACR | Ann Arbor | Michigan | United States | 48109 |
| 66 | Wayne State University | Detroit | Michigan | United States | 48201 |
| 67 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 68 | Nisus Research/Northern Michigan Hospital | Petoskey | Michigan | United States | 49770 |
| 69 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 70 | Michigan Heart P.C. | Ypsilanti | Michigan | United States | 48197 |
| 71 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55414 |
| 72 | VA Medical Center - Cardiology Department | Minneapolis | Minnesota | United States | 55417 |
| 73 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 74 | St. Paul Clinic | St. Paul | Minnesota | United States | 55102 |
| 75 | University Hospitals Clinic | Columbus | Missouri | United States | 65212 |
| 76 | Saint Louis University Hospital | St. Louis | Missouri | United States | 63110 |
| 77 | International Heart Institute Montana Foundation | Missoula | Montana | United States | 59802 |
| 78 | Alegent Health Heart and Vascular Institute | Omaha | Nebraska | United States | 68122 |
| 79 | The Creighton Cardiac Center | Omaha | Nebraska | United States | 68131 |
| 80 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 81 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 82 | Heart Failure & Transplantation Program | Newark | New Jersey | United States | 07112 |
| 83 | Heart Hospital of New Mexico - NW Heart Institute | Albuquerque | New Mexico | United States | 87106 |
| 84 | Jack D. Weiler Hospital/Albert Einstein Hospital | Bronx | New York | United States | 10461 |
| 85 | Montefiore Medical Center/Cardiology Department | Bronx | New York | United States | 10467 |
| 86 | Beth Israel Medical Center NY/Phillips Ambulatory Care Center | New York | New York | United States | 10003 |
| 87 | St. Vincent's Hospital | New York | New York | United States | 10011 |
| 88 | Columbia-Presbyterian Medical Center | New York | New York | United States | 10032 |
| 89 | University Of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 90 | The Lindner Center | Cincinnati | Ohio | United States | 45219 |
| 91 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45219 |
| 92 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
| 93 | Cleveland Clinic Foundation/Department of Cardiology | Cleveland | Ohio | United States | 44195 |
| 94 | OSU Medical Center-Center Wellness & Prevention | Columbus | Ohio | United States | 43210 |
| 95 | The Toledo Clinic & Outpatient Surgery | Toledo | Ohio | United States | 43623 |
| 96 | Toledo Clinic & Outpatient Surgery/Department of Cardiology | Toledo | Ohio | United States | 43623 |
| 97 | Oklahoma Foundation-Cardiovascular | Oklahoma City | Oklahoma | United States | 73104 |
| 98 | University Health Science Center/Cardio Section | Oklahoma City | Oklahoma | United States | 73104 |
| 99 | Hillsboro Cardiology, PC | Hillsboro | Oregon | United States | 97123 |
| 100 | Oregon Health & Science University | Portland | Oregon | United States | 97201 |
| 101 | Providence Portland Medical Center/Heart Failure Clinic | Portland | Oregon | United States | 97213 |
| 102 | Geisinger Health System | Danville | Pennsylvania | United States | 17822 |
| 103 | The Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 104 | Heart Group | Lancaster | Pennsylvania | United States | 17603 |
| 105 | Hahnemann University Hospital/HF and Transplant Center | Philadelphia | Pennsylvania | United States | 19102 |
| 106 | Universtiy of PA Health System | Philadelphia | Pennsylvania | United States | 19104 |
| 107 | Jefferson Heart Institute | Philadelphia | Pennsylvania | United States | 19107 |
| 108 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
| 109 | Buxmont Cardiology Associates | Sellersville | Pennsylvania | United States | 18960 |
| 110 | Cardiology Associates of West Reading | West Reading | Pennsylvania | United States | 19611 |
| 111 | Rhode Island Hospital/University Cardiology | Providence | Rhode Island | United States | 02905 |
| 112 | Baptist Clinical Research Center | Memphis | Tennessee | United States | 38120 |
| 113 | Cardiology Group, P.C. | Tullahoma | Tennessee | United States | 37388 |
| 114 | Austin-Cardiovascular Associates | Austin | Texas | United States | 78705 |
| 115 | Dallas VA Medical Center | Dallas | Texas | United States | 75216 |
| 116 | Cardiopulmonary Research Science & Technology Institute | Dallas | Texas | United States | 75230 |
| 117 | Cardiovascular Research Institute of Dallas | Dallas | Texas | United States | 75231 |
| 118 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 119 | Houston VA Medical Center | Houston | Texas | United States | 77030 |
| 120 | St. Luke's Episcopal Hospital/Texas Heart Institute | Houston | Texas | United States | 77030 |
| 121 | Heart Specialists | Nassau Bay | Texas | United States | 77058 |
| 122 | University of Texas Health Sciences | San Antonio | Texas | United States | 78229 |
| 123 | UTHCT/Center for Clinical Research | Tyler | Texas | United States | 75708 |
| 124 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
| 125 | Carilion Department of Clinical Research | Roanoke | Virginia | United States | 24011 |
| 126 | DUCCS Research of South Boston | South Boston | Virginia | United States | 24592 |
| 127 | Overlake Hospital Medical Center | Bellevue | Washington | United States | 98004 |
| 128 | University of Washington | Seattle | Washington | United States | 98195 |
| 129 | Inland Cardiology Associates | Spokane | Washington | United States | 99204 |
| 130 | Southwest Washington Medical Center | Vancouver | Washington | United States | 98664 |
| 131 | Beloit Clinic, SC | Beloit | Wisconsin | United States | 53511 |
| 132 | St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 133 | Canberra Hospital/Cardiology Department | Garran | Australian Capital Territory | Australia | 2605 |
| 134 | Royal Prince Alfred Hospital/Department of Cardiology | Camperdown | New South Wales | Australia | 2050 |
| 135 | Concord Hospital - Heart Failure Clinic/Department of Cardiology | Concord | New South Wales | Australia | NSW 2139 |
| 136 | Gosford Hospital | Gosford | New South Wales | Australia | |
| 137 | Liverpool Hospital - Cardiology Research | Liverpool | New South Wales | Australia | 2116 |
| 138 | Prince of Wales Hospital | Randwick | New South Wales | Australia | |
| 139 | Royal North Shore Hospital - Cardiology Department | St. Leonards | New South Wales | Australia | |
| 140 | St. George Hospital/Cardiology Department | Sydney | New South Wales | Australia | |
| 141 | Royal Brisbane Hospital - Cardiology Department | Herston | Queensland | Australia | QLD 4029 |
| 142 | The Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 143 | Flinders Medical Centre - Cardiac Research Department | Bedford Park | South Australia | Australia | |
| 144 | Queen Elizabeth Hospital/Cardiology Department | Woodville | South Australia | Australia | 5011 |
| 145 | Royal Hobart Hospital | Hobart | Tasmania | Australia | 7000 |
| 146 | Launceston General Hospital/Cardiac Research Unit | Launceston | Tasmania | Australia | 7250 |
| 147 | Box Hill Hospital - Coronary Care Unit | Box Hill | Victoria | Australia | |
| 148 | St. Vincent's Hospital - Cardiology Investigational Unit | Fitzroy | Victoria | Australia | |
| 149 | Karinia House/Geelong Hospital | Geelong | Victoria | Australia | 3220 |
| 150 | Level 2, Cardiology Department/Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 151 | Heart Research Institute/Sir Charles Gairdner Hospital | Nedlands | Western Australia | Australia | 6009 |
| 152 | University of Calgary | Calgary | Alberta | Canada | T2N 4N1 |
| 153 | Rockyview Hospital, Heart Health Institute | Calgary | Alberta | Canada | T2V 1P9 |
| 154 | University of Alberta Hospitals | Edmonton | Alberta | Canada | T6G 2R7 |
| 155 | University of Ottawa Health Institute | Ottawa | Ontario | Canada | K1Y 4W7 |
| 156 | Neureka Research, Willet Green Niller Centre | Sudbury | Ontario | Canada | P3E 6B4 |
| 157 | Center Hospital University of Sherbrooke | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 158 | University of Saskatchewan | Saskatoon | Saskatchewan | Canada | S7N 3R2 |
| 159 | Barzilai Medical Center | Ashkelon | Israel | 78306 | |
| 160 | Hillel Yaffe Medical Center | Hadera | Israel | 38100 | |
| 161 | Wolfson Medical Center | Holon | Israel | 58100 | |
| 162 | Heart Institute, Hadassah MC | Jerusalem | Israel | 91120 | |
| 163 | EMMS Nazareth Hospital | Nazareth | Israel | 16100 | |
| 164 | Kaplan Medical Center | Rehovot | Israel | 76100 | |
| 165 | Sieff Medical Center | Zefat | Israel | 13100 | |
| 166 | Assaf Harofe Medical Center | Zrifin | Israel | 70300 |
Sponsors and Collaborators
- Abbott
- Orion Corporation, Orion Pharma
Investigators
- Study Director: Scott Krause, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00048425
Other Study ID Numbers:
- 3001069
First Posted:
Nov 4, 2002
Last Update Posted:
Dec 15, 2006
Last Verified:
Dec 1, 2006
Keywords provided by ,
,
Additional relevant MeSH terms: