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| Sponsor: | Abbott |
|---|---|
| Collaborator: |
Orion Corporation, Orion Pharma |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00048425 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Heart Failure, Congestive |
Drug: Levosimendan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy 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. |
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | December 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following criteria would exclude the patient from study:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Cardiology, P.C. Research | |
| Birmingham, Alabama, United States, 35211 | |
| Cardiovascular Associates/Office of Clinical Research | |
| Birmingham, Alabama, United States, 35209 | |
| Providence Hospital Heart Failure Clinic | |
| Mobile, Alabama, United States, 36685 | |
| Oracle Research-The Heart Center | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Sarver Heart Center - University of Arizona Health Science | |
| Tucson, Arizona, United States, 85724 | |
| Arizona Heart Institute | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Arkansas | |
| Central Arkansas Veterans Healthcare System | |
| Little Rock, Arkansas, United States, 72205 | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Los Angeles County/USC Medical Center | |
| Los Angeles, California, United States, 90033 | |
| Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Apex Cardiology Consultants, Inc. | |
| Inglewood, California, United States, 90301 | |
| UCSD Medical Center, University of California | |
| San Diego, California, United States, 92103 | |
| San Diego Cardiovascular Research | |
| Encinitas, California, United States, 92024 | |
| San Diego Cardiac Center | |
| San Diego, California, United States, 92123 | |
| Central Cardiology Medical Center | |
| Bakersfield, California, United States, 93301 | |
| A.R.I. Clinical Trials, Inc. | |
| Redondo Beach, California, United States, 90277 | |
| Cardiovascular Medical Group & Research Institute | |
| Beverly Hills, California, United States, 90210 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Sacramento Heart and Vascular Research Center | |
| Sacramento, California, United States, 95825 | |
| VA Greater Los Angeles Healthcare System | |
| Los Angeles, California, United States, 90073 | |
| VA Hospital of San Francisco | |
| San Francisco, California, United States, 94121 | |
| VA San Diego Healthcare System | |
| San Diego, California, United States, 92161 | |
| Merced Heart Associates | |
| Merced, California, United States, 95340 | |
| United States, Colorado | |
| Denver Health Medical Center | |
| Denver, Colorado, United States, 80204 | |
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| Yale University School of Medicine/Heart Failure Center | |
| New Haven, Connecticut, United States, 06510 | |
| Hospital of Saint Raphael | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Delaware | |
| Christiana Care Health System | |
| Newark, Delaware, United States, 19718 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20037 | |
| Washington Hospital Center - Cardiac Surgery Department | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Heart & Vascular Institute of Florida | |
| St. Petersburg, Florida, United States, 33701 | |
| Watson Clinic Center for Research | |
| Lakeland, Florida, United States, 33805 | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Jacksonville Heart Center PA-Baptist Office | |
| Jacksonville, Florida, United States, 32207 | |
| MIMA Century Research Associates | |
| Melbourne, Florida, United States, 32901 | |
| Jacksonville Heart Center,PA | |
| Jacksonville, Florida, United States, 32250 | |
| The Ford Research Institute PA/NW Florida Heart Group PA | |
| Pensacola, Florida, United States, 32514 | |
| Florida Cardiovascular Institute | |
| Tampa, Florida, United States, 33609 | |
| Victor Howard M.D., P.A. Heart Research Center | |
| Port Charlotte, Florida, United States, 33952 | |
| Jackson Memorial Hospital | |
| Miami, Florida, United States, 33102 | |
| Miami Research & Education Foundation | |
| Miami, Florida, United States, 33156 | |
| United States, Georgia | |
| Memorial Health University Medical Center Research Center | |
| Savannah, Georgia, United States, 31405 | |
| Augusta Cardiology Clinic, P.C. | |
| Augusta, Georgia, United States, 30901 | |
| United States, Illinois | |
| Northwestern Memorial Hospital/Heart Failure Program | |
| Chicago, Illinois, United States, 60611 | |
| Heart Care Midwest | |
| Peoria, Illinois, United States, 61603 | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Elgin Cardiology Associates | |
| Elgin, Illinois, United States, 60120 | |
| Midwest Heart Research Foundation | |
| Lombard, Illinois, United States, 60148 | |
| United States, Indiana | |
| Clarian Health - Methodist Research Institute Inc. | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University Hospital, Iowa City | |
| Iowa City, Iowa, United States, 52242 | |
| Iowa Heart Center | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Kansas | |
| Via Christi Research Inc. dba PriVia | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Gill Heart Institute/University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Louisiana | |
| Cardiac Centers of Louisiana, LLC | |
| Shreveport, Louisiana, United States, 71135 | |
| New Orleans Clinical Trial Management, Inc. | |
| Covington, Louisiana, United States, 70433 | |
| Louisiana Heart Center | |
| Chalmette, Louisiana, United States, 70043 | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Medical Research Institute | |
| Slidell, Louisiana, United States, 70458 | |
| United States, Maryland | |
| University of Maryland Hospital | |
| Baltimore, Maryland, United States, 21201 | |
| The Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| John Hopkins Bayview Medical Center | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| Nisus Research/Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Michigan Heart P.C. | |
| Ypsilanti, Michigan, United States, 48197 | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| University of Michigan Medical Center, CACR | |
| Ann Arbor, Michigan, United States, 48109 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| VA Medical Center - Cardiology Department | |
| Minneapolis, Minnesota, United States, 55417 | |
| St. Paul Clinic | |
| St. Paul, Minnesota, United States, 55102 | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States, 55414 | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Saint Louis University Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| University Hospitals Clinic | |
| Columbus, Missouri, United States, 65212 | |
| United States, Montana | |
| International Heart Institute Montana Foundation | |
| Missoula, Montana, United States, 59802 | |
| United States, Nebraska | |
| Alegent Health Heart and Vascular Institute | |
| Omaha, Nebraska, United States, 68122 | |
| The Creighton Cardiac Center | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Heart Failure & Transplantation Program | |
| Newark, New Jersey, United States, 07112 | |
| United States, New Mexico | |
| Heart Hospital of New Mexico - NW Heart Institute | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Columbia-Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| Beth Israel Medical Center NY/Phillips Ambulatory Care Center | |
| New York, New York, United States, 10003 | |
| St. Vincent's Hospital | |
| New York, New York, United States, 10011 | |
| Jack D. Weiler Hospital/Albert Einstein Hospital | |
| Bronx, New York, United States, 10461 | |
| Montefiore Medical Center/Cardiology Department | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| University Of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45219 | |
| The Lindner Center | |
| Cincinnati, Ohio, United States, 45219 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Toledo Clinic & Outpatient Surgery/Department of Cardiology | |
| Toledo, Ohio, United States, 43623 | |
| OSU Medical Center-Center Wellness & Prevention | |
| Columbus, Ohio, United States, 43210 | |
| The Toledo Clinic & Outpatient Surgery | |
| Toledo, Ohio, United States, 43623 | |
| Cleveland Clinic Foundation/Department of Cardiology | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| University Health Science Center/Cardio Section | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Oklahoma Foundation-Cardiovascular | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97201 | |
| Hillsboro Cardiology, PC | |
| Hillsboro, Oregon, United States, 97123 | |
| Providence Portland Medical Center/Heart Failure Clinic | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Cardiology Associates of West Reading | |
| West Reading, Pennsylvania, United States, 19611 | |
| The Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Geisinger Health System | |
| Danville, Pennsylvania, United States, 17822 | |
| Buxmont Cardiology Associates | |
| Sellersville, Pennsylvania, United States, 18960 | |
| Hahnemann University Hospital/HF and Transplant Center | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Heart Group | |
| Lancaster, Pennsylvania, United States, 17603 | |
| Jefferson Heart Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Universtiy of PA Health System | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Rhode Island Hospital/University Cardiology | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| Cardiology Group, P.C. | |
| Tullahoma, Tennessee, United States, 37388 | |
| Baptist Clinical Research Center | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Cardiovascular Research Institute of Dallas | |
| Dallas, Texas, United States, 75231 | |
| Heart Specialists | |
| Nassau Bay, Texas, United States, 77058 | |
| Houston VA Medical Center | |
| Houston, Texas, United States, 77030 | |
| Dallas VA Medical Center | |
| Dallas, Texas, United States, 75216 | |
| University of Texas Health Sciences | |
| San Antonio, Texas, United States, 78229 | |
| UTHCT/Center for Clinical Research | |
| Tyler, Texas, United States, 75708 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Austin-Cardiovascular Associates | |
| Austin, Texas, United States, 78705 | |
| St. Luke's Episcopal Hospital/Texas Heart Institute | |
| Houston, Texas, United States, 77030 | |
| Cardiopulmonary Research Science & Technology Institute | |
| Dallas, Texas, United States, 75230 | |
| United States, Virginia | |
| DUCCS Research of South Boston | |
| South Boston, Virginia, United States, 24592 | |
| Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
| Carilion Department of Clinical Research | |
| Roanoke, Virginia, United States, 24011 | |
| United States, Washington | |
| Inland Cardiology Associates | |
| Spokane, Washington, United States, 99204 | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Overlake Hospital Medical Center | |
| Bellevue, Washington, United States, 98004 | |
| Southwest Washington Medical Center | |
| Vancouver, Washington, United States, 98664 | |
| United States, Wisconsin | |
| Beloit Clinic, SC | |
| Beloit, Wisconsin, United States, 53511 | |
| St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Australia, Australian Capital Territory | |
| Canberra Hospital/Cardiology Department | |
| Garran, Australian Capital Territory, Australia, 2605 | |
| Australia, New South Wales | |
| Concord Hospital - Heart Failure Clinic/Department of Cardiology | |
| Concord, New South Wales, Australia, NSW 2139 | |
| Royal North Shore Hospital - Cardiology Department | |
| St. Leonards, New South Wales, Australia | |
| Prince of Wales Hospital | |
| Randwick, New South Wales, Australia | |
| Gosford Hospital | |
| Gosford, New South Wales, Australia | |
| Royal Prince Alfred Hospital/Department of Cardiology | |
| Camperdown, New South Wales, Australia, 2050 | |
| St. George Hospital/Cardiology Department | |
| Sydney, New South Wales, Australia | |
| Liverpool Hospital - Cardiology Research | |
| Liverpool, New South Wales, Australia, 2116 | |
| Australia, Queensland | |
| Royal Brisbane Hospital - Cardiology Department | |
| Herston, Queensland, Australia, QLD 4029 | |
| The Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, South Australia | |
| Flinders Medical Centre - Cardiac Research Department | |
| Bedford Park, South Australia, Australia | |
| Queen Elizabeth Hospital/Cardiology Department | |
| Woodville, South Australia, Australia, 5011 | |
| Australia, Tasmania | |
| Royal Hobart Hospital | |
| Hobart, Tasmania, Australia, 7000 | |
| Launceston General Hospital/Cardiac Research Unit | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Box Hill Hospital - Coronary Care Unit | |
| Box Hill, Victoria, Australia | |
| St. Vincent's Hospital - Cardiology Investigational Unit | |
| Fitzroy, Victoria, Australia | |
| Level 2, Cardiology Department/Royal Melbourne Hospital | |
| Parkville, Victoria, Australia, 3050 | |
| Karinia House/Geelong Hospital | |
| Geelong, Victoria, Australia, 3220 | |
| Australia, Western Australia | |
| Heart Research Institute/Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Canada, Alberta | |
| University of Alberta Hospitals | |
| Edmonton, Alberta, Canada, T6G 2R7 | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Rockyview Hospital, Heart Health Institute | |
| Calgary, Alberta, Canada, T2V 1P9 | |
| Canada, Ontario | |
| University of Ottawa Health Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Neureka Research, Willet Green Niller Centre | |
| Sudbury, Ontario, Canada, P3E 6B4 | |
| Canada, Quebec | |
| Center Hospital University of Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Canada, Saskatchewan | |
| University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 3R2 | |
| Israel | |
| Kaplan Medical Center | |
| Rehovot, Israel, 76100 | |
| Heart Institute, Hadassah MC | |
| Jerusalem, Israel, 91120 | |
| Sieff Medical Center | |
| Zefat, Israel, 13100 | |
| Wolfson Medical Center | |
| Holon, Israel, 58100 | |
| Barzilai Medical Center | |
| Ashkelon, Israel, 78306 | |
| Hillel Yaffe Medical Center | |
| Hadera, Israel, 38100 | |
| Assaf Harofe Medical Center | |
| Zrifin, Israel, 70300 | |
| EMMS Nazareth Hospital | |
| Nazareth, Israel, 16100 | |
| Study Director: | Scott Krause | Abbott |
More Information
| Study ID Numbers: | 3001069 |
| Study First Received: | October 31, 2002 |
| Last Updated: | December 14, 2006 |
| ClinicalTrials.gov Identifier: | NCT00048425 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Decompensated chronic heart failure |
|
Heart Failure Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents |
Protective Agents Pharmacologic Actions Simendan Phosphodiesterase Inhibitors Therapeutic Uses Cardiovascular Diseases Anti-Arrhythmia Agents |