The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).

Condition	Treatment or Intervention	Phase
Congestive Heart Failure	Drug: Tolvaptan	Phase III

Study Design: Multicenter, randomized, double-blind, placebo-controlled

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age greater than or equal to 18 years.
• Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization. The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (>1+); or c) dyspnea.
• NYHA Class III or IV at the time of hospitalization.
• Left Ventricular Ejection Fraction < = 40% within one year.

Exclusion Criteria

• Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form.
• Positive urine pregnancy test.
• Inability to provide written informed consent.
• Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions.
• Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment.
• Subjects who are on cardiac mechanical support.
• History of bi-ventricular pacer placement within the last 60 days.
• Co-morbid condition with an expected survival less than six months.
• Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization.
• History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
• History of a cerebrovascular accident within the last 30 days.
• Hemodynamically significant uncorrected primary cardiac valvular disease.
• Hypertrophic cardiomyopathy (obstructive or non-obstructive).
• CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
• Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes.
• History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
• History of poorly controlled diabetes mellitus.
• Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI > 40.
• Supine systolic arterial blood pressure < 90 mmHg.
• Serum creatinine > 3.5 mg/dL or > 309.4 mmol/L.
• Serum potassium > 5.5 mEq/L or > 5.5 mmol/L.
• Hemoglobin < 9 g/dL or < 90 g/L.
• History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril).
• History of drug or medication abuse within the past year, or current alcohol abuse.
• Inability to take oral medications.
• Participation in another clinical drug or device trial within the past 30 days.
• Previous participation in this or any other tolvaptan clinical trial.

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Alabama
      The Heart Group, Mobile,  Alabama,  36608,  United States; Recruiting
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
      The Heart Center, Huntsville,  Alabama,  35801,  United States; Recruiting
Arizona
      Saguaro Clinical Research, Tucson,  Arizona,  85712,  United States; Recruiting
      Phoenix Memorial Hospital, Gilbert,  Arizona,  85233,  United States; Recruiting
      Arizona Heart Institute, Phoenix,  Arizona,  85006,  United States; Recruiting
Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
      Central Arkansas Veterans Healthcare Systems, Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      Bakersfield Memorial Hospital, Bakersfield,  California,  93301,  United States; No longer recruiting
      LAC/USC Medical Center, Los Angeles,  California,  90033,  United States; Recruiting
      San Diego Cardiac Center, San Diego,  California,  92123,  United States; Recruiting
      Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States; Recruiting
      Central Cardiology Medical Center, Bakersfield,  California,  93301,  United States; Recruiting
      ARI Clinical Trials, Redondo Beach,  California,  92077,  United States; Recruiting
      Mission Internal Medical Group, Mission Viejo,  California,  92691,  United States; Recruiting
      Cardiovascular Consultants Medical Group, Inc., Walnut Creek,  California,  94598,  United States; Recruiting
      VA Medical Center- W. Los Angeles, Los Angeles,  California,  90073,  United States; Recruiting
      Cardiology Associates, Larkspur,  California,  94939,  United States; Recruiting
      Pacific Heart Institute, Santa Monica,  California,  90404,  United States; Recruiting
Colorado
      Heart and Vascular Clinic of North Colorado, Fort Collins,  Colorado,  80528,  United States; Recruiting
      University of Colorado, Denver,  Colorado,  80262,  United States; Recruiting
      Aurora Denver Cardiology Associates, Denver,  Colorado,  80218,  United States; Recruiting
Connecticut
      Bakus Resesarch, Norwich,  Connecticut,  06360,  United States; Recruiting
District of Columbia
      VA Medical Center, Washington,  District of Columbia,  20422,  United States; Recruiting
Florida
      Cardiovascular Center of Sarasota, Sarasota,  Florida,  34239,  United States; Recruiting
      Cardiology Research Associates, Ormond Beach,  Florida,  32174,  United States; Recruiting
      Charlotte Heart Group Research Center, Port Charlotte,  Florida,  33952,  United States; Recruiting
      Jacksonville Heart Center, Jacksonville,  Florida,  32207,  United States; Recruiting
      Ocala Resarch Institute, Ocala,  Florida,  34480,  United States; Recruiting
      Florida Cardiovascular Research, Atlantis,  Florida,  33462,  United States; Recruiting
      Cardiology Associates of Fort Lauderdale, Fort Lauderdale,  Florida,  33308,  United States; Recruiting
      Jacksonville Heart Center, Jacksonville Beach,  Florida,  32250,  United States; Recruiting
      The Heart and Vascular Institute of Florida, St. Petersburg,  Florida,  33701,  United States; Recruiting
      University of Miami/ Jackson Memorial Hospital, Miami,  Florida,  33136,  United States; Recruiting
      Melbourne Internal Medicine Assoc., Melbourne,  Florida,  32901,  United States; Recruiting
      Miami Research and Education Foundation, Miami,  Florida,  33156,  United States; Recruiting
      Jacksonville Center for Clinical Research, Jacksonville,  Florida,  32216,  United States; Not yet recruiting
Georgia
      Georgia Heart Specialists, Covington,  Georgia,  30014,  United States; Recruiting
      Atlanta Heart and Vascular Research Group, Atlanta,  Georgia,  30342,  United States; Recruiting
      Cardiac Disease Specialists PC, Atlanta,  Georgia,  30309,  United States; Not yet recruiting
Idaho
      Idaho Cardiology Associates, Meridian,  Idaho,  83642,  United States; Recruiting
      Idaho Cardiology Associates, Boise,  Idaho,  83704,  United States; Recruiting
Illinois
      North Shore Cardiologists, Bannockburn,  Illinois,  60015,  United States; Recruiting
      Heart Care Midwest, Peoria,  Illinois,  61603,  United States; Recruiting
      Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
      Illinois Heart & Lung Associates, Normal,  Illinois,  61761,  United States; Recruiting
      Midwest Heart Research Found., Lombard,  Illinois,  60148,  United States; Recruiting
Indiana
      The Care Group, Indianapolis,  Indiana,  46260,  United States; Recruiting
Kansas
      Mid America Cardiology, Kansas City,  Kansas,  66160,  United States; Recruiting
Kentucky
      Louisville Cardiology Medical Group, Louisville,  Kentucky,  40207,  United States; Recruiting
      Cardiovascular Associates, Louisville,  Kentucky,  40205,  United States; Recruiting
Louisiana
      Lousiana State University Health Sciences Center, Shreveport,  Louisiana,  71103,  United States; Recruiting
      Northshore Medical Research, Covington,  Louisiana,  70433,  United States; Recruiting
      Cardiac Centers of LA, LLC, Shreveport,  Louisiana,  71135,  United States; Recruiting
      The Louisiana Heart Center, Chalmette,  Louisiana,  70043,  United States; Recruiting
      Leonard J Chabert Medical Center, Houma,  Louisiana,  70360,  United States; Not yet recruiting
Maine
      Androscoggin Cardiology Associates, Auburn,  Maine,  04210,  United States; Recruiting
      Northeast Cardiology Associates, Bangor,  Maine,  04401,  United States; Recruiting
      Maine Medical Center, Portland,  Maine,  04102,  United States; Recruiting
Maryland
      Shore Health System, Easton,  Maryland,  21601,  United States; Recruiting
      MidAtlantic Cardiovascular Associates, Baltimore,  Maryland,  21218,  United States; Recruiting
      MidAtlantic Cardiovascular Associates, Baltimore,  Maryland,  21237,  United States; Recruiting
      MidAtlantic Cardiovascular Associates, Westminster,  Maryland,  21157,  United States; Recruiting
      MidAtlantic Cardiovascular Associates, Towson,  Maryland,  21204,  United States; Recruiting
      Midatlantic Cardiovascular Associates, Bel Air,  Maryland,  21014,  United States; Not yet recruiting
      Heart Associates, P.A., Towson,  Maryland,  21286,  United States; Not yet recruiting
      Midatlantic Cardiovascular Associates, Baltimore,  Maryland,  21229,  United States; Recruiting
Massachusetts
      Primary Care Cardiology Research, Ayer,  Massachusetts,  01432,  United States; Recruiting
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
      Beth Israel Medical Center, Boston,  Massachusetts,  02215,  United States; Not yet recruiting
Michigan
      Nisus Research, Petoskey,  Michigan,  49770,  United States; Recruiting
      John Dingell VA Medical Center, Detroit,  Michigan,  48201,  United States; Recruiting
      Covenant Medical Center, Saginaw,  Michigan,  48602,  United States; Recruiting
      William Beaumont Hospital, Royal Oak,  Michigan,  48073-1026,  United States; Recruiting
      Beaumont Hospital, Troy,  Michigan,  48085,  United States; Recruiting
      Michigan Heart, Ypsilanti,  Michigan,  48197,  United States; Recruiting
Minnesota
      St. Paul Heart Clinic, St. Paul,  Minnesota,  55102,  United States; Recruiting
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States; Recruiting
      Mayo Clinic, Division of Cardiology, Rochester,  Minnesota,  55905,  United States; Recruiting
      Hennepin County Medical Center, Minneapolis,  Minnesota,  55416,  United States; Recruiting
      Minneapolis Heart Institute, Minneapolis,  Minnesota,  55407,  United States; Recruiting
      Park Nicollet Heart Center, St. Louis Park,  Minnesota,  55426,  United States; Recruiting
      Regions Hospital Cardiology Research, St. Paul,  Minnesota,  55101,  United States; Recruiting
Mississippi
      Cardiology Associates of North Mississippi, Tupelo,  Mississippi,  38801,  United States; Recruiting
Missouri
      Missouri Cardiovascular Specialists, Columbia,  Missouri,  65201,  United States; Recruiting
      St. Louis University, St. Louis,  Missouri,  63110,  United States; Recruiting
      VA Medical Center- Kansas City, Kansas City,  Missouri,  64128,  United States; Recruiting
Nebraska
      Heart Consultants, Omaha,  Nebraska,  68122,  United States; Recruiting
      Bryan LGH Heart Institute, Lincoln,  Nebraska,  68516,  United States; Recruiting
New Hampshire
      New England Heart Institute, Manchester,  New Hampshire,  03102,  United States; Recruiting
New Jersey
      Morristown Memorial Hospital, Morristown,  New Jersey,  07962-1956,  United States; Recruiting
      Garden State Cardiology, Paramus,  New Jersey,  07652,  United States; Recruiting
      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112,  United States; Recruiting
New York
      South Bay Cardiovascular Associates, West Islip,  New York,  11795,  United States; Recruiting
      New York Presbyterian Hospital, New York,  New York,  10032,  United States; Not yet recruiting
      SUNY, Syracuse,  New York,  13230,  United States; Recruiting
      Buffalo Cardiology and Pulmonary Associates, Williamsville,  New York,  14221,  United States; Recruiting
      St. Vincents Hospital and Medical Center, New York,  New York,  10011,  United States; Recruiting
      St. Francis Hospital, Roslyn,  New York,  11576,  United States; Recruiting
      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
      Albany Associates in Cardiology, Albany,  New York,  12212,  United States; Not yet recruiting
      Cardiology Associates, P.C., Johnson City,  New York,  13790,  United States; Recruiting
      St. Lukes-Roosevelt Hospital Centers, New York,  New York,  10019,  United States; Not yet recruiting
North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27514,  United States; Recruiting
      Durham VA Medical Center, Durham,  North Carolina,  27705,  United States; Recruiting
      Alamance Regional Medical Center, Burlington,  North Carolina,  27215,  United States; Recruiting
      Hendersonville Cardiology, Hendersonville,  North Carolina,  28739,  United States; Recruiting
      Asheville Cardiology Associates, Asheville,  North Carolina,  28803,  United States; Recruiting
      Mid Carolina Cardiology, Charlotte,  North Carolina,  28204,  United States; Recruiting
      Duke Cardiology Research, Durham,  North Carolina,  27710,  United States; Recruiting
      Pitt County Memorial Hospital, The Heart Center, Greenville,  North Carolina,  28735,  United States; Recruiting
Ohio
      The Dayton Heart Center, Dayton,  Ohio,  45414,  United States; Recruiting
      Akron General Medical Center, Akron,  Ohio,  44307,  United States; Recruiting
      North Ohio Research Limited, Sandusky,  Ohio,  44870,  United States; Recruiting
      The Lindner Clinical Trial Center, Cincinnati,  Ohio,  45219,  United States; Recruiting
      Northwest Ohio Cardiology Consultants, Toledo,  Ohio,  43615,  United States; Recruiting
      North Ohio Research Limited, Lorain,  Ohio,  44052,  United States; Recruiting
      Cleveland Cardiovascular Research, Fairview Park,  Ohio,  44126,  United States; Recruiting
      Sterling Research Group, Cincinnati,  Ohio,  45219,  United States; Recruiting
      Clinical Research Limited, Canton,  Ohio,  44718,  United States; Recruiting
      Midwest Cardiology Research Foundation, Columbus,  Ohio,  43214,  United States; Recruiting
Oklahoma
      Integris Heart Research Center, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      Oklahoma Cardiovascular Research Group, Oklahoma City,  Oklahoma,  73120,  United States; Recruiting
Pennsylvania
      The Western Pennsylvania Hospital, Pittsburgh,  Pennsylvania,  15224,  United States; Recruiting
      Guthrie Clinic, LTD, Sayre,  Pennsylvania,  18840,  United States; Recruiting
      Cardiology Associates of West Reading, West Reading,  Pennsylvania,  19611,  United States; Recruiting
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02905,  United States; Recruiting
South Carolina
      South Carolina Heart Center, Columbia,  South Carolina,  29204,  United States; Recruiting
      Ralph H. Johnson VAMC, Charleston,  South Carolina,  29401,  United States; Recruiting
      Medical University of South Carolina, Charleston,  South Carolina,  29401,  United States; Recruiting
Tennessee
      The Cardiology Group, Tullahoma,  Tennessee,  37388,  United States; Recruiting
      Baptist Clinical Research Center, Memphis,  Tennessee,  38120,  United States; Recruiting
      Vanderbilt Clinical Trials Center, Nashville,  Tennessee,  37212,  United States; Recruiting
      Stern Cardiovascular Center, Memphis,  Tennessee,  38120,  United States; Recruiting
      The Chattanooga Heart Institute, Chattanooga,  Tennessee,  37404,  United States; Recruiting
      Cardiovascular Associates, Kingsport,  Tennessee,  37660,  United States; Recruiting
Texas
      Cardiopulmonary Research Science and Technology Institute, Dallas,  Texas,  75230,  United States; Recruiting
      Scott & White Clinic Division of Cardiology, Temple,  Texas,  76508,  United States; Recruiting
      Wilford Hall Medical Center,, San Antonio,  Texas,  78236,  United States; Recruiting
      University of Texas Health Science Center, San Antonio,  Texas,  78229-3900,  United States; Not yet recruiting
      Austin Cardiovascular Associates, Austin,  Texas,  78705,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555-0553,  United States; Recruiting
      Southeast Texas Cardiology Associates, Beaumont,  Texas,  77702,  United States; Recruiting
      Cardiology Associates Covenant Medical Group, Lubbock,  Texas,  79410,  United States; Recruiting
Virginia
      Cardiovascular Associates of Virginia, Richmond,  Virginia,  23225,  United States; Recruiting
      University of Virginia Medical Center, Charlottesville,  Virginia,  22908,  United States; Recruiting
      Inova Institute of Research, Falls Church,  Virginia,  22042,  United States; Recruiting
      Medical College of Virginia, Richmond,  Virginia,  23219,  United States; Recruiting
      Roanoke Heart Institute, Roanoke,  Virginia,  24014,  United States; Recruiting
      The Cardiovascular Group PC, Fairfax,  Virginia,  22031,  United States; Recruiting
Washington
      Empire Health Services, Spokane,  Washington,  99204,  United States; Recruiting
      Rockwood Clinic, Spokane,  Washington,  99204,  United States; Recruiting
Wisconsin
      Wisconsin Center For Clinical Research, Elkhorn,  Wisconsin,  53121,  United States; Recruiting
Argentina
      Hospital Privado Antartida, Capital Federal,  Argentina; Recruiting
      Policinica Bancaria, Capital Federal,  Argentina; Not yet recruiting
      Hospital Argerich, Buenos Aires,  Argentina; Recruiting
      Hospital Churruca, Buenos Aires,  Argentina; Recruiting
      Hospital Italiano de Cordoba, Cordoba,  Argentina; Not yet recruiting
      Hospital Privado Centro Medico de Cordoba, Cordoba,  Argentina; Recruiting
      Instituto de Cardiologia J. F. Cabral, Corrientes,  Argentina; Recruiting
      Clinica Modelo de Moron, Buenos Aires,  Argentina; Not yet recruiting
      Hospital Ramos Mejia, Capital Federal,  Argentina; Recruiting
      Hospital Eva Peron, Buenos Aires,  Argentina; Recruiting
      Hospital de Clinicas, Capital Federal,  Argentina; Recruiting
      Hospital Militar de Cordoba, Cordoba,  Argentina; Not yet recruiting
      Hospital Fernandez, Capital Federal,  Argentina; Not yet recruiting
      Clinica Constituyentes de Moron, Buenos Aires,  Argentina; Recruiting
      Hospital Allende, Cordoba,  Argentina; Not yet recruiting
      Sanatorio Municipal "Julio A. Mendez", Capital Federal,  Argentina; Recruiting
      Fundacion Favaloro, Buenos Aires,  Argentina; Not yet recruiting
      Hospital Italiano de Buenos Aires, Capital Federal,  Argentina; Not yet recruiting
      Hospital Nacional Dr. Alejandro Posadas, Buenos Aires,  Argentina; Not yet recruiting
      Hospital Central de San Isidro, San Isidro,  Argentina; Not yet recruiting
Belgium
      Clinique St Elisabeth Place Louise, Namur,  Belgium; Recruiting
      AZ Imelda Ziekenhuis, Bonheiden,  Belgium; Recruiting
      Cliniques UCL Mont-Godinne, Yvoir,  Belgium; Not yet recruiting
      AZ Middelheim, Antwerpen,  Belgium; Recruiting
Brazil
      Hospital Universitario Pedro Ernesto, Rio de Janeiro,  20551-030,  Brazil; Not yet recruiting
      Hospital Universitario Onofre Lopes, Natal,  59012-310,  Brazil; Not yet recruiting
      Hospital das Clínicas de Porto Alegre, Porto Alegre,  90035-003,  Brazil; Not yet recruiting
Brazil, BA
      Hospital Santa Isabel da Santa Casa de Misericordia da Bahia, Salvador,  BA,  40050-410,  Brazil; Not yet recruiting
      Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos, Salvador,  BA,  40140-060,  Brazil; Not yet recruiting
Brazil, GO
      Hospital das Clinicas da Universidade Federal de Goias, Goiania,  GO,  74605-050,  Brazil; Not yet recruiting
Brazil, MG
      Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte,  MG,  30150-221,  Brazil; Recruiting
      Hospital Governador Israel Pinheiro, Belo Horizonte,  MG,  30130-110,  Brazil; Not yet recruiting
Brazil, PR
      Hospital Evangelico de Curitiba, Curitiba,  PR,  80730-150,  Brazil; Recruiting
      Hospital Nossa Senhora das Gracas, Curitiba,  PR,  80810-040,  Brazil; Not yet recruiting
Brazil, RJ
      Santa Casa de Misericordia do Rio de Janeiro, Rio de Janeiro,  RJ,  20020-020,  Brazil; Not yet recruiting
Brazil, RS
      Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre,  RS,  90020-090,  Brazil; Recruiting
      Hospital Mae de Deus, Porto Alegre,  RS,  90880-480,  Brazil; Not yet recruiting
      Hospital Nossa Senhora da Conceica, Porto Alegre,  RS,  91350-200,  Brazil; Not yet recruiting
      Hospital das Clínicas de Porto Alegre, Porto Alegre,  RS,  90035-003,  Brazil; Not yet recruiting
Brazil, SP
      Instituto do Coracao do Hospital das Clinicas- Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo,  SP,  05403-000,  Brazil; Recruiting
      IMC- Instituto de Molestias Cardiovasculares, Sao Jose do Rio Preto,  SP,  15015-210,  Brazil; Recruiting
      Hospital de Base da Faculdade de Medicina de Sao Jose do Rio Preto, Sao Jose de Rio Preto,  SP,  15090-020,  Brazil; Recruiting
      Hospital e Maternidade Celso Pierro, Campinas,  SP,  13059-740,  Brazil; Not yet recruiting
Canada, Alberta
      Peter Loougheed Center, Calgary,  Alberta,  T1Y6J4,  Canada; Not yet recruiting
Canada, British Columbia
      Victoria Heart Institute Foundation, Victoria,  British Columbia,  V8R4R2,  Canada; Recruiting
      Surrey Memorial Hospital, Surrey,  British Columbia,  V3V1Z2,  Canada; Not yet recruiting
Canada, Manitoba
      St. Boniface General Hospital, Winnipeg,  Manitoba,  R2H 2A6,  Canada; Recruiting
Canada, Newfoundland and Labrador
      Health Sciences Center, St. John's,  Newfoundland and Labrador,  A1B 3V6,  Canada; Recruiting
Canada, Ontario
      Lakeridge Health Oshawa, Oshawa,  Ontario,  L1G2B9,  Canada; Recruiting
      Greater Niagara General Hospital, Niagara Falls,  Ontario,  L2E6Y2,  Canada; Recruiting
      Cardiology Research Associates, Scarborough,  Ontario,  M2S4V5,  Canada; Recruiting
      Brampton Research Associates, Brampton,  Ontario,  L6V1B4,  Canada; Not yet recruiting
      Scarborough Cardiology Research, Scarborough,  Ontario,  M1E5E9,  Canada; Recruiting
      University Health Network, Toronto Western Hospital, Toronto,  Ontario,  M5G 2C4,  Canada; Not yet recruiting
      St. Michael's Hospital, Toronto,  Ontario,  M5B 1W8,  Canada; Not yet recruiting
      The Scarborough Hospital, Toronto,  Ontario,  M1P 2V5,  Canada; Recruiting
Canada, Quebec
      Montreal Heart Institute, Montreal,  Quebec,  H1T1C8,  Canada; Recruiting
      Royal Victoria Hospital, Montreal,  Quebec,  H3A1A1,  Canada; Not yet recruiting
      CHRDL, Joliette,  Quebec,  J6E6J2,  Canada; Recruiting
      Invascor Clinical Research, Longueuil,  Quebec,  J4M 1E1,  Canada; Recruiting
      Centre Hospitalier de l'Universite de Sherbrooke, Fleurimond,  Quebec,  J1H 5N4,  Canada; Recruiting
      Hotel-Dieu de Saint-Jerome, Saint-Jerome,  Quebec,  J7Z 5T3,  Canada; Not yet recruiting
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada; Not yet recruiting
Czech Republic
      Kardiologicke oddeleni, Praha,  Czech Republic; Recruiting
      I.Interni oddeleni, Praha,  Czech Republic; Recruiting
      Interni klinika, Oddeleni Interna I, Kardiologie, Pardubice,  Czech Republic; Recruiting
      I. interni kardio-angiologicka klinika LF MU, Brno,  Czech Republic; Recruiting
      II.Interni klinika, Praha,  Czech Republic; Recruiting
      Klinika kardiologie, Praha,  Czech Republic; Not yet recruiting
      Interni oddeleni, Pisek,  Czech Republic; Recruiting
      Interni klinika IPVZ, Zlin,  Czech Republic; Recruiting
      I.Interni klinika, Plzen-Lochotin,  Czech Republic; No longer recruiting
      Interni oddeleni, Usti nad Labem,  Czech Republic; Recruiting
      Interni oddeleni, Jablonec nad Nisou,  Czech Republic; Recruiting
      Kardiologicka klinika, Praha,  Czech Republic; Not yet recruiting
      Interni oddeleni, Nachod,  Czech Republic; Recruiting
France
      Hopital Louis Pradel, Bron cedex,  France; Recruiting
      Hopital General Henri Duffaut, Avignon,  France; Recruiting
      CHU Montpellier, Montpellier,  France; Recruiting
      Groupe Hospitalier Rangueil-Larrey CHU, Toulouse,  31403,  France; Recruiting
      Centre Hospitalier Regional d'Arras-Service de Cardiologie, Arras,  France; Recruiting
      Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie, Nantes Cedex,  44093,  France; Recruiting
      Centre Cardiologique du Nord, Saint Denis,  France; Recruiting
      Hopital Pasteur, Nice,  France; Recruiting
      Centre Hospitalier Jeanne d'Arc, Bar-le-Duc,  France; Recruiting
      Cabinet de Cardiologie et d'Explorations, Essey lès Nancy Cedex,  France; Recruiting
      Centre Hospitalier, Langres,  France; Recruiting
      Centre Hospitalier Universitaire de Nancy-Brabois, Vandoeuvre-les-Nancy,  France; Recruiting
Germany
      Marienkrankenhaus Soest, Soest,  Germany; Recruiting
      Vivantes Klinikum Neukoln, Berlin,  Germany; Recruiting
      Universitatsklinikum Heidelberg, Heidelberg,  Germany; Recruiting
      Universitatsklinik Essen, ESSEN,  Germany; Recruiting
      Friedrich Schiller Universitat Jena, Jena,  Germany; Recruiting
      University Leipzig, Leipzig,  Germany; Not yet recruiting
      Georg-August-Universitat Gottingen, Gottingen,  Germany; Recruiting
      Klinikum der Medizinischen Fakultat, Halle,  Germany; Recruiting
      Robert-Bosch-Krankenhaus, Stuttgart,  Germany; Recruiting
      Universitatsklinikum Eppendorf, Hamburg,  Germany; Recruiting
      Klinikum der Universitat zu Koln, Koln,  Germany; Not yet recruiting
      Universitatsklinikum des Saarland, HOMBURG / SAAR,  Germany; Recruiting
      Universitatsklinikum der, Greifswald,  Germany; Recruiting
      Herz- und Diabetes Zentrum Nordrhein-Westfalen, Oeyenhausen,  Germany; Recruiting
      Herz- und Gefabklinik Bad Neustadt, Bad Neustadt-Saale,  Germany; Recruiting
      Akademisches Lehrkrankenhaus d. HGS Essen, ESSEN,  Germany; Recruiting
      Universitat Regensburg, Regensburg,  Germany; Recruiting
      Klinikum Augsburg, Augsburg,  Germany; Recruiting
      Herzzentrum Bad Krozingen, Bad Krozingen,  Germany; Recruiting
      Universitatsklinikum Munster, Munster,  Germany; Not yet recruiting
      Medizinische Universitätsklinik, Heidelberg,  Germany; Recruiting
Italy
      IRCCS Policlinico S. Matteo, Pavia,  Italy; Recruiting
      Azienda USL n. 6 Ospedale Civile, Cecina,  Italy; Recruiting
      Ospedale S. Bartolomeo, Sarzana,  Italy; Not yet recruiting
      Azienda Ospedaliera S. Michele, Cagliari,  Italy; Recruiting
      Ospedale Civile S. Giuseppe, Albano Laziale,  Italy; Recruiting
      IRCCS- Fondazione Salvatore Maugeri, Pavia,  Italy; Recruiting
      Poliambulatorio Valdichiana Ospedale di Cortona, Cortona,  Italy; Not yet recruiting
      Ospedale Civile, Capri,  Italy; Not yet recruiting
      Ospedali Riunti, Parma,  Italy; Recruiting
      Ospedali Civile SS Annunziata, Sassari,  Italy; Recruiting
      Presidio Ospedaliero Villa Sofia, Palmero,  Italy; Recruiting
      Fondazione Salvatore Maugeri, Montescano,  Italy; Recruiting
      Ospedale S. Maria delle Grazie, Pozzuoli,  Italy; Recruiting
      Centro Cardiologico Monzino, Milano,  Italy; Recruiting
      Ospedale Nigaurda Ca Granda, Milano,  Italy; Not yet recruiting
Netherlands
      Canisius-Wilhelmina Ziekenhuis, Nijmegen,  Netherlands; Recruiting
      Oosterschelde Ziekenhuizen, Goes,  Netherlands; Recruiting
      Gelre Ziekenhuis (location Juliana), Apeldoorn,  Netherlands; Recruiting
      Ziekenhuis Gooi Noord, Blaricum,  Netherlands; Recruiting
      Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG), Den Bosch,  Netherlands; Recruiting
      Deventer Ziekenhuis, Deventer,  Netherlands; Not yet recruiting
      Ziekenhuis Gelderse Vallei, Ede,  Netherlands; Not yet recruiting
      Medisch Spectrum Twente, ENSCHEDE,  Netherlands; Recruiting
      Martini Ziekenhuis (Loc. Martini Paviljoen), Groningen,  Netherlands; Recruiting
      Spaarne Ziekenhuis, Heemstede,  Netherlands; Recruiting
      Isala Klinieken (Loc. Sophia), Zwolle,  Netherlands; Not yet recruiting
      Sint Lucas Andreas Ziekenhuis (loc. Lucas), Amsterdam,  Netherlands; Recruiting
      Ziekenhuis Hilversum, Hilversum,  Netherlands; Recruiting
      Medisch Centrum Haaglanden (location Westeinde), Den Haag,  Netherlands; Recruiting
Norway
      Hjertemed.avd. Akershus Universitetssykenhus, Nordbyhagen,  Norway; Recruiting
      Hjerte med. Avd. Haukeland Universitets Sykehus, BERGEN,  Norway; Recruiting
      Med. Avd. Sykenhuset Telemark, Skien,  Norway; Recruiting
      Stavanger Helseforskning, Stavanger,  Norway; Recruiting
      Nordlandsykehuset, Bodo,  Norway; Recruiting
      Diakonhjemmets sykehus Oslo, Oslo,  Norway; Not yet recruiting
Poland
      I Klinika Choroby Wiencowej, Warszawa,  Poland; Recruiting
      Oddzial Kardiologii, Sieradz,  Poland; Recruiting
      Oddzial Kardiologii, Torun,  Poland; Recruiting
      Oddzial Kardiologii, Lodz,  Poland; Recruiting
      Oddzial Kardiologii, Krakow,  Poland; Recruiting
      Oddzial Kardiologiczny, Opole,  Poland; Recruiting
      Oddzial Kardiologiczny, Piotrków Trybunalski,  Poland; Recruiting
      Oddzial Kardiologiczny, Plock,  Poland; Recruiting
      Oddzial Chorob Wewnetrznych, Olawa,  Poland; Recruiting
      Oddzial Kardiologii, Ostrowiec Swietokrzyski,  Poland; Recruiting
      Katedra i Klinika Chorab Wewnetrznych i Kardiologii, Warszawa,  Poland; Recruiting
      Oddzial Kardiologii, Wloclawek,  Poland; Recruiting
      Oddzial Kardiologii, Bydgoszcz,  Poland; Recruiting
      Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii, Tychy,  Poland; Recruiting
Romania
      Institutul Inimii, Prof.N. Stancioiu, Cluj Napoca,  Romania; Recruiting
      Spitalul Universitar de Urgenta, Bucuresti,  Romania; Recruiting
      Spitalul Clinic Universitar ,,Sf. Spiridon", Iasi,  Romania; Recruiting
      Spitalul Universitar de Urgenta Bucuresti, Bucharest,  Romania; Recruiting
      Centrul de Cardiologie Craiova, Craiova,  Romania; Recruiting
      Institutul de Boli Cardiovasculare, Bucharest,  Romania; Recruiting
      Spitalul Caritas, Clinica Medicala, Bucharest,  Romania; Recruiting
      Spitalul de Urgenta Floreasca, Clinica de Cardiologie, Bucharest,  Romania; Recruiting
      Institutul de Boli Cardiovasculare, Bucharest,  Romania; Recruiting
      Spitalul Clinic Judetean Mures, Targu Mures,  Romania; Recruiting
      Institutul de Boli Cardiovasculare Timisoara, Timisoara,  Romania; Recruiting
      Spitalul Judetean Brasov, Sectia de Cardiologie, Brasov,  Romania; Recruiting
Spain
      Hospital Clinic y Provincial, Barcelona,  Spain; Recruiting
      Hospital Reina Sofia, in Cordoba, Cordoba,  Spain; Recruiting
      Hospital Universitari de Tarragona Joan XXIII, Tarragona,  Spain; Not yet recruiting
      Hospital Doce de Octubre, Madrid,  Spain; Not yet recruiting
      Hospital Severo Ochoa, Madrid,  Spain; Recruiting
      Hospital de Cruces, Bilbao,  Spain; Recruiting
      Hospital General Universitario de Valencia, Valencia,  Spain; Recruiting
      Hospital de Torrecardenas, Almeria,  Spain; Not yet recruiting
Sweden
      Enheten for internmedicin, Karolinska Institutet, Stockholm,  Sweden; Not yet recruiting
      Kardiologkliniken, Stockholm,  Sweden; Not yet recruiting
      Medicinkliniken, Goteborg,  Sweden; Recruiting
      Kardiologkliniken, MALMO,  Sweden; Not yet recruiting
      Hjartcentrum,, Umea,  Sweden; Not yet recruiting
      Cardiologkliniken, Avd 50F, Uppsala,  Sweden; Not yet recruiting
      Kardiologkliniken, Linkoping,  Sweden; Not yet recruiting
      Forskiningsenheten,, Molndal,  Sweden; Not yet recruiting
      Hjartkliniken, M84, Stockholm,  Sweden; Not yet recruiting
      Avd. for intermedicin, GOTHENBURG,  Sweden; Not yet recruiting
Switzerland
      Cardiocentro Ticino, Lugano,  Switzerland; Not yet recruiting
United Kingdom
      Castle Hill Hospital, Cottingham,  United Kingdom; Recruiting
      Northern Manchester General Hospital, Manchester,  United Kingdom; Recruiting
      Leeds General Infirmary, Leeds,  United Kingdom; Recruiting
      Bradford Royal Infirmary, Bradford,  United Kingdom; Recruiting
      Scunthorpe General Hospital, Scunthorpe,  United Kingdom; Recruiting

Study ID Numbers:  156-03-236
Record last reviewed:  September 2004
Record first received:  October 20, 2003
ClinicalTrials.gov Identifier:  NCT00071331
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10