NCT00071331

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
3,600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2003

Typical duration for phase_3

Geographic Reach
18 countries

378 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

May 3, 2012

Status Verified

May 1, 2012

Enrollment Period

2.8 years

First QC Date

October 20, 2003

Last Update Submit

May 2, 2012

Conditions

Keywords

chronic heart failureheart failure

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (378)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

The Heart Center

Huntsville, Alabama, 35801, United States

Location

The Heart Group

Mobile, Alabama, 36608, United States

Location

Phoenix Memorial Hospital

Gilbert, Arizona, 85233, United States

Location

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Saguaro Clinical Research

Tucson, Arizona, 85712, United States

Location

Central Arkansas Veterans Healthcare Systems

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Bakersfield Memorial Hospital

Bakersfield, California, 93301, United States

Location

Central Cardiology Medical Center

Bakersfield, California, 93301, United States

Location

Cardiology Associates

Larkspur, California, 94939, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

LAC/USC Medical Center

Los Angeles, California, 90033, United States

Location

VA Medical Center- W. Los Angeles

Los Angeles, California, 90073, United States

Location

Mission Internal Medical Group

Mission Viejo, California, 92691, United States

Location

ARI Clinical Trials

Redondo Beach, California, 92077, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Cardiovascular Consultants Medical Group, Inc.

Walnut Creek, California, 94598, United States

Location

Aurora Denver Cardiology Associates

Denver, Colorado, 80218, United States

Location

University of Colorado

Denver, Colorado, 80262, United States

Location

Heart and Vascular Clinic of North Colorado

Fort Collins, Colorado, 80528, United States

Location

Bakus Resesarch

Norwich, Connecticut, 06360, United States

Location

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Florida Cardiovascular Research

Atlantis, Florida, 33462, United States

Location

Cardiology Associates of Fort Lauderdale

Fort Lauderdale, Florida, 33308, United States

Location

Jacksonville Heart Center

Jacksonville, Florida, 32207, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Jacksonville Heart Center

Jacksonville Beach, Florida, 32250, United States

Location

Melbourne Internal Medicine Assoc.

Melbourne, Florida, 32901, United States

Location

University of Miami/ Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Miami Research and Education Foundation

Miami, Florida, 33156, United States

Location

Ocala Resarch Institute

Ocala, Florida, 34480, United States

Location

Cardiology Research Associates

Ormond Beach, Florida, 32174, United States

Location

Charlotte Heart Group Research Center

Port Charlotte, Florida, 33952, United States

Location

Cardiovascular Center of Sarasota

Sarasota, Florida, 34239, United States

Location

The Heart and Vascular Institute of Florida

St. Petersburg, Florida, 33701, United States

Location

Cardiac Disease Specialists PC

Atlanta, Georgia, 30309, United States

Location

Atlanta Heart and Vascular Research Group

Atlanta, Georgia, 30342, United States

Location

Georgia Heart Specialists

Covington, Georgia, 30014, United States

Location

Idaho Cardiology Associates

Boise, Idaho, 83704, United States

Location

Idaho Cardiology Associates

Meridian, Idaho, 83642, United States

Location

North Shore Cardiologists

Bannockburn, Illinois, 60015, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Midwest Heart Research Found.

Lombard, Illinois, 60148, United States

Location

Illinois Heart & Lung Associates

Normal, Illinois, 61761, United States

Location

Heart Care Midwest

Peoria, Illinois, 61603, United States

Location

The Care Group

Indianapolis, Indiana, 46260, United States

Location

Mid America Cardiology

Kansas City, Kansas, 66160, United States

Location

Cardiovascular Associates

Louisville, Kentucky, 40205, United States

Location

Louisville Cardiology Medical Group

Louisville, Kentucky, 40207, United States

Location

The Louisiana Heart Center

Chalmette, Louisiana, 70043, United States

Location

Northshore Medical Research

Covington, Louisiana, 70433, United States

Location

Leonard J Chabert Medical Center

Houma, Louisiana, 70360, United States

Location

Lousiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Cardiac Centers of LA, LLC

Shreveport, Louisiana, 71135, United States

Location

Androscoggin Cardiology Associates

Auburn, Maine, 04210, United States

Location

Northeast Cardiology Associates

Bangor, Maine, 04401, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

MidAtlantic Cardiovascular Associates

Baltimore, Maryland, 21218, United States

Location

Midatlantic Cardiovascular Associates

Baltimore, Maryland, 21229, United States

Location

MidAtlantic Cardiovascular Associates

Baltimore, Maryland, 21237, United States

Location

Midatlantic Cardiovascular Associates

Bel Air, Maryland, 21014, United States

Location

Shore Health System

Easton, Maryland, 21601, United States

Location

MidAtlantic Cardiovascular Associates

Towson, Maryland, 21204, United States

Location

Heart Associates, P.A.

Towson, Maryland, 21286, United States

Location

MidAtlantic Cardiovascular Associates

Westminster, Maryland, 21157, United States

Location

Primary Care Cardiology Research

Ayer, Massachusetts, 01432, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Medical Center

Boston, Massachusetts, 02215, United States

Location

John Dingell VA Medical Center

Detroit, Michigan, 48201, United States

Location

Nisus Research

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073-1026, United States

Location

Covenant Medical Center

Saginaw, Michigan, 48602, United States

Location

Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55416, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic, Division of Cardiology

Rochester, Minnesota, 55905, United States

Location

Park Nicollet Heart Center

Saint Louis Park, Minnesota, 55426, United States

Location

Regions Hospital Cardiology Research

Saint Paul, Minnesota, 55101, United States

Location

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801, United States

Location

Missouri Cardiovascular Specialists

Columbia, Missouri, 65201, United States

Location

VA Medical Center- Kansas City

Kansas City, Missouri, 64128, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Bryan LGH Heart Institute

Lincoln, Nebraska, 68516, United States

Location

Heart Consultants

Omaha, Nebraska, 68122, United States

Location

New England Heart Institute

Manchester, New Hampshire, 03102, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962-1956, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07103, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Garden State Cardiology

Paramus, New Jersey, 07652, United States

Location

Albany Associates in Cardiology

Albany, New York, 12212, United States

Location

Cardiology Associates, P.C.

Johnson City, New York, 13790, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

St. Vincents Hospital and Medical Center

New York, New York, 10011, United States

Location

St. Lukes-Roosevelt Hospital Centers

New York, New York, 10019, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

SUNY

Syracuse, New York, 13230, United States

Location

South Bay Cardiovascular Associates

West Islip, New York, 11795, United States

Location

Buffalo Cardiology and Pulmonary Associates

Williamsville, New York, 14221, United States

Location

Asheville Cardiology Associates

Asheville, North Carolina, 28803, United States

Location

Alamance Regional Medical Center

Burlington, North Carolina, 27215, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Mid Carolina Cardiology

Charlotte, North Carolina, 28204, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Duke Cardiology Research

Durham, North Carolina, 27710, United States

Location

Pitt County Memorial Hospital, The Heart Center

Greenville, North Carolina, 28735, United States

Location

Hendersonville Cardiology

Hendersonville, North Carolina, 28739, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Clinical Research Limited

Canton, Ohio, 44718, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45219, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Midwest Cardiology Research Foundation

Columbus, Ohio, 43214, United States

Location

The Dayton Heart Center

Dayton, Ohio, 45414, United States

Location

Cleveland Cardiovascular Research

Fairview Park, Ohio, 44126, United States

Location

North Ohio Research Limited

Lorain, Ohio, 44052, United States

Location

North Ohio Research Limited

Sandusky, Ohio, 44870, United States

Location

Northwest Ohio Cardiology Consultants

Toledo, Ohio, 43615, United States

Location

Integris Heart Research Center

Oklahoma City, Oklahoma, 73112, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Oregon Health and Science University

Portland, Oregon, 97230, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

The Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Guthrie Clinic, LTD

Sayre, Pennsylvania, 18840, United States

Location

Buxmont Cardiology Associates, PC

Sellersville, Pennsylvania, 18960, United States

Location

Cardiology Associates of West Reading

West Reading, Pennsylvania, 19611, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

Ralph H. Johnson VAMC

Charleston, South Carolina, 29401, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

The Chattanooga Heart Institute

Chattanooga, Tennessee, 37404, United States

Location

Cardiovascular Associates

Kingsport, Tennessee, 37660, United States

Location

Baptist Clinical Research Center

Memphis, Tennessee, 38120, United States

Location

Stern Cardiovascular Center

Memphis, Tennessee, 38120, United States

Location

Vanderbilt Clinical Trials Center

Nashville, Tennessee, 37212, United States

Location

The Cardiology Group

Tullahoma, Tennessee, 37388, United States

Location

Austin Cardiovascular Associates

Austin, Texas, 78705, United States

Location

Southeast Texas Cardiology Associates

Beaumont, Texas, 77702, United States

Location

Cardiopulmonary Research Science and Technology Institute

Dallas, Texas, 75230, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0553, United States

Location

Cardiology Associates Covenant Medical Group

Lubbock, Texas, 79410, United States

Location

McAllen Heart Clinic

McAllen, Texas, 78503, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229-3900, United States

Location

Wilford Hall Medical Center,

San Antonio, Texas, 78236, United States

Location

Scott & White Clinic Division of Cardiology

Temple, Texas, 76508, United States

Location

VA Salt Lake City Health Care System

Salt Lake City, Utah, 84148, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

The Cardiovascular Group PC

Fairfax, Virginia, 22031, United States

Location

Inova Institute of Research

Falls Church, Virginia, 22042, United States

Location

Medical College of Virginia

Richmond, Virginia, 23219, United States

Location

Cardiovascular Associates of Virginia

Richmond, Virginia, 23225, United States

Location

Roanoke Heart Institute

Roanoke, Virginia, 24014, United States

Location

Empire Health Services

Spokane, Washington, 99204, United States

Location

Rockwood Clinic

Spokane, Washington, 99204, United States

Location

CAMC Clinical Trials

Charleston, West Virginia, 25304, United States

Location

Wisconsin Center For Clinical Research

Elkhorn, Wisconsin, 53121, United States

Location

Clinica Constituyentes de Moron

Buenos Aires, Argentina

Location

Clinica Modelo de Moron

Buenos Aires, Argentina

Location

Fundacion Favaloro

Buenos Aires, Argentina

Location

Hospital Argerich

Buenos Aires, Argentina

Location

Hospital Churruca

Buenos Aires, Argentina

Location

Hospital Eva Peron

Buenos Aires, Argentina

Location

Hospital Nacional Dr. Alejandro Posadas

Buenos Aires, Argentina

Location

Hospital de Clinicas

Capital Federal, Argentina

Location

Hospital Fernandez

Capital Federal, Argentina

Location

Hospital Italiano de Buenos Aires

Capital Federal, Argentina

Location

Hospital Privado Antartida

Capital Federal, Argentina

Location

Hospital Ramos Mejia

Capital Federal, Argentina

Location

Policlinica Bancaria

Capital Federal, Argentina

Location

Sanatorio Municipal "Julio A. Mendez"

Capital Federal, Argentina

Location

Instituto de Cardiologia J. F. Cabral

Corrientes, Argentina

Location

Hospital Allende

Córdoba, Argentina

Location

Hospital Italiano de Cordoba

Córdoba, Argentina

Location

Hospital Militar de Cordoba

Córdoba, Argentina

Location

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Location

Hospital Central de San Isidro

San Isidro, Argentina

Location

AZ Middelheim

Antwerp, Belgium

Location

AZ Imelda Ziekenhuis

Bonheiden, Belgium

Location

Clinique St Elisabeth Place Louise

Namur, Belgium

Location

Cliniques UCL Mont-Godinne

Yvoir, Belgium

Location

Hospital Santa Isabel da Santa Casa de Misericordia da Bahia

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos

Salvador, Estado de Bahia, 40140-060, Brazil

Location

Hospital das Clinicas da Universidade Federal de Goias

Goiânia, Goiás, 74605-050, Brazil

Location

Hospital Governador Israel Pinheiro

Belo Horizonte, Minas Gerais, 30130-110, Brazil

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Hospital Evangelico de Curitiba

Curitiba, Paraná, 80730-150, Brazil

Location

Hospital Nossa Senhora das Gracas

Curitiba, Paraná, 80810-040, Brazil

Location

Santa Casa de Misericordia do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20020-020, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital das Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

Location

Hospital Nossa Senhora da Conceica

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital e Maternidade Celso Pierro

Campinas, São Paulo, 13059-740, Brazil

Location

Hospital de Base da Faculdade de Medicina de Sao Jose do Rio Preto

Sao Jose de Rio Preto, São Paulo, 15090-020, Brazil

Location

IMC- Instituto de Molestias Cardiovasculares

São José do Rio Preto, São Paulo, 15015-210, Brazil

Location

Instituto do Coracao do Hospital das Clinicas- Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Hospital Universitario Onofre Lopes

Natal, 59012-310, Brazil

Location

Hospital das Clínicas de Porto Alegre

Porto Alegre, 90035-003, Brazil

Location

Hospital Universitario Pedro Ernesto

Rio de Janeiro, 20551-030, Brazil

Location

Peter Loougheed Center

Calgary, Alberta, T1Y6J4, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, V3V1Z2, Canada

Location

Victoria Heart Institute Foundation

Victoria, British Columbia, V8R4R2, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Center

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Brampton Research Associates

Brampton, Ontario, L6V1B4, Canada

Location

Greater Niagara General Hospital

Niagara Falls, Ontario, L2E6Y2, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G2B9, Canada

Location

Scarborough Cardiology Research

Scarborough Village, Ontario, M1E5E9, Canada

Location

Cardiology Research Associates

Scarborough Village, Ontario, M2S4V5, Canada

Location

The Scarborough Hospital

Toronto, Ontario, M1P 2V5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network, Toronto Western Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Centre Hospitalier de l'Universite de Sherbrooke

Fleurimond, Quebec, J1H 5N4, Canada

Location

CHRDL

Joliette, Quebec, J6E6J2, Canada

Location

Invascor Clinical Research

Longueuil, Quebec, J4M 1E1, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Hotel-Dieu de Saint-Jerome

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

I. interni kardio-angiologicka klinika LF MU

Brno, Czechia

Location

Interni oddeleni

Jablonec nad Nisou, Czechia

Location

Interni oddeleni

Náchod, Czechia

Location

Interni klinika, Oddeleni Interna I, Kardiologie

Pardubice, Czechia

Location

Interni oddeleni

Písek, Czechia

Location

I.Interni klinika

Plzen-Lochotin, Czechia

Location

I.Interni oddeleni

Prague, Czechia

Location

II.Interni klinika

Prague, Czechia

Location

Kardiologicka klinika

Prague, Czechia

Location

Kardiologicke oddeleni

Prague, Czechia

Location

Klinika kardiologie

Prague, Czechia

Location

Interni oddeleni

Ústí nad Labem, Czechia

Location

Interni klinika IPVZ

Zlín, Czechia

Location

Centre Hospitalier Regional d'Arras-Service de Cardiologie

Arras, France

Location

Hopital General Henri Duffaut

Avignon, France

Location

Centre Hospitalier Jeanne d'Arc

Bar-le-Duc, France

Location

Hopital Louis Pradel

Bron, France

Location

Cabinet de Cardiologie et d'Explorations

Essey-lès-Nancy, France

Location

Centre Hospitalier

Langres, France

Location

CHU Montpellier

Montpellier, France

Location

Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie

Nantes, 44093, France

Location

Hopital Pasteur

Nice, France

Location

Centre Cardiologique du Nord

Saint-Denis, France

Location

Groupe Hospitalier Rangueil-Larrey CHU

Toulouse, 31403, France

Location

Centre Hospitalier Universitaire de Nancy-Brabois

Vandœuvre-lès-Nancy, France

Location

Klinikum Augsburg

Augsburg, Germany

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Herz- und Gefabklinik Bad Neustadt

Bad Neustadt-Saale, Germany

Location

Vivantes Klinikum Neukoln

Berlin, Germany

Location

Klinikum der Universitat zu Koln

Cologne, Germany

Location

Akademisches Lehrkrankenhaus d. HGS Essen

Essen, Germany

Location

Universitatsklinik Essen

Essen, Germany

Location

Georg-August-Universitat Gottingen

Göttingen, Germany

Location

Universitatsklinikum der

Greifswald, Germany

Location

Klinikum der Medizinischen Fakultat

Halle, Germany

Location

Universitatsklinikum Eppendorf

Hamburg, Germany

Location

Medizinische Universitätsklinik

Heidelberg, Germany

Location

Universitatsklinikum Heidelberg

Heidelberg, Germany

Location

Universitatsklinikum des Saarland

Homburg/Saar, Germany

Location

Friedrich Schiller Universitat Jena

Jena, Germany

Location

University Leipzig

Leipzig, Germany

Location

Universitatsklinikum Munster

Münster, Germany

Location

Herz- und Diabetes Zentrum Nordrhein-Westfalen

Oeyenhausen, Germany

Location

Universitat Regensburg

Regensburg, Germany

Location

Marienkrankenhaus Soest

Soest, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, Germany

Location

Ospedale Civile S. Giuseppe

Albano Laziale, Italy

Location

Azienda Ospedaliera S. Michele

Cagliari, Italy

Location

Ospedale Civile

Capri city, Italy

Location

Azienda USL n. 6 Ospedale Civile

Cecina, Italy

Location

Poliambulatorio Valdichiana Ospedale di Cortona

Cortona, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Ospedale Nigaurda Ca Granda

Milan, Italy

Location

Fondazione Salvatore Maugeri

Montescano, Italy

Location

Presidio Ospedaliero Villa Sofia

Palmero, Italy

Location

Ospedali Riunti

Parma, Italy

Location

IRCCS Policlinico S. Matteo

Pavia, Italy

Location

IRCCS- Fondazione Salvatore Maugeri

Pavia, Italy

Location

Ospedale S. Maria delle Grazie

Pozzuoli, Italy

Location

Ospedale S. Bartolomeo

Sarzana, Italy

Location

Ospedali Civile SS Annunziata

Sassari, Italy

Location

Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG)

's-Hertogenbosch, Netherlands

Location

Sint Lucas Andreas Ziekenhuis (loc. Lucas)

Amsterdam, Netherlands

Location

Gelre Ziekenhuis (location Juliana)

Apeldoorn, Netherlands

Location

Ziekenhuis Gooi Noord

Blaricum, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Oosterschelde Ziekenhuizen

Goes, Netherlands

Location

Martini Ziekenhuis (Loc. Martini Paviljoen)

Groningen, Netherlands

Location

Spaarne Ziekenhuis

Heemstede, Netherlands

Location

Ziekenhuis Hilversum

Hilversum, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Medisch Centrum Haaglanden (location Westeinde)

The Hague, Netherlands

Location

Isala Klinieken (Loc. Sophia)

Zwolle, Netherlands

Location

Hjerte med. Avd. Haukeland Universitets Sykehus

Bergen, Norway

Location

Nordlandsykehuset

Bodø, Norway

Location

Hjertemed.avd. Akershus Universitetssykenhus

Nordbyhagen, Norway

Location

Diakonhjemmets sykehus Oslo

Oslo, Norway

Location

Med. Avd. Sykenhuset Telemark

Skien, Norway

Location

Stavanger Helseforskning

Stavanger, Norway

Location

Oddzial Kardiologii

Bydgoszcz, Poland

Location

Oddzial Kardiologii

Krakow, Poland

Location

Oddzial Kardiologii

Lodz, Poland

Location

Oddzial Kardiologiczny

Opole, Poland

Location

Oddzial Kardiologii

Ostrowiec Świętokrzyski, Poland

Location

Oddzial Chorob Wewnetrznych

Oława, Poland

Location

Oddzial Kardiologiczny

Piotrkow Trybunalski, Poland

Location

Oddzial Kardiologiczny

Płock, Poland

Location

Oddzial Kardiologii

Sieradz, Poland

Location

Oddzial Kardiologii

Torun, Poland

Location

Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii

Tychy, Poland

Location

I Klinika Choroby Wiencowej

Warsaw, Poland

Location

Katedra i Klinika Chorab Wewnetrznych i Kardiologii

Warsaw, Poland

Location

Oddzial Kardiologii

Włocławek, Poland

Location

Spitalul Judetean Brasov, Sectia de Cardiologie

Brasov, Romania

Location

Institutul de Boli Cardiovasculare

Bucharest, Romania

Location

Spitalul Caritas, Clinica Medicala

Bucharest, Romania

Location

Spitalul de Urgenta Floreasca, Clinica de Cardiologie

Bucharest, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, Romania

Location

Spitalul Universitar de Urgenta

Bucharest, Romania

Location

Institutul Inimii, Prof.N. Stancioiu

Cluj-Napoca, Romania

Location

Centrul de Cardiologie Craiova

Craiova, Romania

Location

Spitalul Clinic Universitar ,,Sf. Spiridon"

Iași, Romania

Location

Spitalul Clinic Judetean Mures

Târgu Mureş, Romania

Location

Institutul de Boli Cardiovasculare Timisoara

Timișoara, Romania

Location

Botkins Moscow City Hospital

Moscow, Russia

Location

Burdenko Main Military Clinical Hospital

Moscow, Russia

Location

Cardiology Research Center

Moscow, Russia

Location

Central Clinical Hospital Presidential

Moscow, Russia

Location

City Clinical Hospital 2

Moscow, Russia

Location

Institute of Physico-Chemical Medicine

Moscow, Russia

Location

Medical Center of General Management

Moscow, Russia

Location

Moscow Medical Academy

Moscow, Russia

Location

Moscow Regional Research Clinical Institute n.a. Vishnevsky

Moscow, Russia

Location

Moscow State University of Medicine and Dentistry - City Hospital #11

Moscow, Russia

Location

Moscow State University of Medicine and Dentistry - City Hospital #40

Moscow, Russia

Location

Moscow State University of Medicine and Dentistry

Moscow, Russia

Location

Russian State Medical University

Moscow, Russia

Location

Veterans Hospital #3

Moscow, Russia

Location

Cardiology Research Institute of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

Location

City Alexandrovsky Hospital, ICU Department

Saint Petersburg, Russia

Location

City Hospital #31

Saint Petersburg, Russia

Location

City Hospital 8

Saint Petersburg, Russia

Location

Military Medical Academy

Saint Petersburg, Russia

Location

St. Elisabeth City Hospital

Saint Petersburg, Russia

Location

St. Petersburg Clinical Hospital of Russian Academy of Sciences

Saint Petersburg, Russia

Location

St. Petersburg Dzanelidze State Scientific Research Institute for Emergency Medical Care

Saint Petersburg, Russia

Location

St. Petersburg Medical Postgraduate Academy

Saint Petersburg, Russia

Location

St. Petersburg State University

Saint Petersburg, Russia

Location

Hospital de Torrecardenas

Almería, Spain

Location

Hospital Clinic y Provincial

Barcelona, Spain

Location

Hospital de Cruces

Bilbao, Spain

Location

Hospital Reina Sofia, in Cordoba

Córdoba, Spain

Location

Hospital Doce de Octubre

Madrid, Spain

Location

Hospital Severo Ochoa

Madrid, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

Avd. for intermedicin

Gothenburg, Sweden

Location

Medicinkliniken

Gothenburg, Sweden

Location

Kardiologkliniken

Linköping, Sweden

Location

Kardiologkliniken

Malmo, Sweden

Location

Forskiningsenheten,

Mölndal, Sweden

Location

Enheten for internmedicin, Karolinska Institutet

Stockholm, Sweden

Location

Hjartkliniken, M84

Stockholm, Sweden

Location

Kardiologkliniken

Stockholm, Sweden

Location

Hjartcentrum,

Umeå, Sweden

Location

Cardiologkliniken, Avd 50F

Uppsala, Sweden

Location

Cardiocentro Ticino

Lugano, Switzerland

Location

Bradford Royal Infirmary

Bradford, United Kingdom

Location

Castle Hill Hospital

Cottingham, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Northern Manchester General Hospital

Manchester, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, United Kingdom

Location

Related Publications (12)

  • Oka T, Tighiouart H, McCallum W, Tuttle M, Isaka Y, Konstam MA, Udelson JE, Sarnak MJ. Thresholds of Kidney Function Decline and Congestion Status and Their Relation with Outcomes among Discharged Heart Failure Patients. Clin J Am Soc Nephrol. 2025 Jul 11;20(9):1215-1225. doi: 10.2215/CJN.0000000768.

  • Hejjaji V, Tang Y, Coles T, Jones PG, Reeve BB, Mentz RJ, Spatz ES, Dunlay SM, Caldwell B, Saha A, Tarver ME, Tran A, Patel KK, Henke D, Pina IL, Spertus JA. Psychometric Evaluation of the Kansas City Cardiomyopathy Questionnaire in Men and Women With Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008284. doi: 10.1161/CIRCHEARTFAILURE.120.008284. Epub 2021 Sep 1.

  • Ter Maaten JM, Valente MA, Damman K, Cleland JG, Givertz MM, Metra M, O'Connor CM, Teerlink JR, Ponikowski P, Bloomfield DM, Cotter G, Davison B, Subacius H, van Veldhuisen DJ, van der Meer P, Hillege HL, Gheorghiade M, Voors AA. Combining Diuretic Response and Hemoconcentration to Predict Rehospitalization After Admission for Acute Heart Failure. Circ Heart Fail. 2016 Jun;9(6):e002845. doi: 10.1161/CIRCHEARTFAILURE.115.002845.

  • Ambrosy AP, Khan H, Udelson JE, Mentz RJ, Chioncel O, Greene SJ, Vaduganathan M, Subacuis HP, Konstam MA, Swedberg K, Zannad F, Maggioni AP, Gheorghiade M, Butler J. Changes in Dyspnea Status During Hospitalization and Postdischarge Health-Related Quality of Life in Patients Hospitalized for Heart Failure: Findings From the EVEREST Trial. Circ Heart Fail. 2016 May;9(5):e002458. doi: 10.1161/CIRCHEARTFAILURE.115.002458.

  • Mentz RJ, Greene SJ, Ambrosy AP, Vaduganathan M, Subacius HP, Swedberg K, Maggioni AP, Nodari S, Ponikowski P, Anker SD, Butler J, Gheorghiade M. Clinical profile and prognostic value of anemia at the time of admission and discharge among patients hospitalized for heart failure with reduced ejection fraction: findings from the EVEREST trial. Circ Heart Fail. 2014 May;7(3):401-8. doi: 10.1161/CIRCHEARTFAILURE.113.000840. Epub 2014 Apr 15.

  • Hauptman PJ, Burnett J, Gheorghiade M, Grinfeld L, Konstam MA, Kostic D, Krasa HB, Maggioni A, Ouyang J, Swedberg K, Zannad F, Zimmer C, Udelson JE; Everest Investigators. Clinical course of patients with hyponatremia and decompensated systolic heart failure and the effect of vasopressin receptor antagonism with tolvaptan. J Card Fail. 2013 Jun;19(6):390-7. doi: 10.1016/j.cardfail.2013.04.001. Epub 2013 May 14.

  • Ambrosy AP, Vaduganathan M, Mentz RJ, Greene SJ, Subacius H, Konstam MA, Maggioni AP, Swedberg K, Gheorghiade M. Clinical profile and prognostic value of low systolic blood pressure in patients hospitalized for heart failure with reduced ejection fraction: insights from the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST) trial. Am Heart J. 2013 Feb;165(2):216-25. doi: 10.1016/j.ahj.2012.11.004. Epub 2012 Dec 29.

  • Allen LA, Gheorghiade M, Reid KJ, Dunlay SM, Chan PS, Hauptman PJ, Zannad F, Konstam MA, Spertus JA. Identifying patients hospitalized with heart failure at risk for unfavorable future quality of life. Circ Cardiovasc Qual Outcomes. 2011 Jul;4(4):389-98. doi: 10.1161/CIRCOUTCOMES.110.958009. Epub 2011 Jun 21.

  • O'Connor CM, Miller AB, Blair JE, Konstam MA, Wedge P, Bahit MC, Carson P, Haass M, Hauptman PJ, Metra M, Oren RM, Patten R, Pina I, Roth S, Sackner-Bernstein JD, Traver B, Cook T, Gheorghiade M; Efficacy of Vasopressin Antagonism in heart Failure Outcome Study with Tolvaptan (EVEREST) investigators. Causes of death and rehospitalization in patients hospitalized with worsening heart failure and reduced left ventricular ejection fraction: results from Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) program. Am Heart J. 2010 May;159(5):841-849.e1. doi: 10.1016/j.ahj.2010.02.023.

  • Blair JE, Zannad F, Konstam MA, Cook T, Traver B, Burnett JC Jr, Grinfeld L, Krasa H, Maggioni AP, Orlandi C, Swedberg K, Udelson JE, Zimmer C, Gheorghiade M; EVEREST Investigators. Continental differences in clinical characteristics, management, and outcomes in patients hospitalized with worsening heart failure results from the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) program. J Am Coll Cardiol. 2008 Nov 11;52(20):1640-8. doi: 10.1016/j.jacc.2008.07.056.

  • Gheorghiade M, Konstam MA, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: the EVEREST Clinical Status Trials. JAMA. 2007 Mar 28;297(12):1332-43. doi: 10.1001/jama.297.12.1332. Epub 2007 Mar 25.

  • Konstam MA, Gheorghiade M, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA. 2007 Mar 28;297(12):1319-31. doi: 10.1001/jama.297.12.1319. Epub 2007 Mar 25.

MeSH Terms

Conditions

Heart Failure

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 20, 2003

First Posted

October 21, 2003

Study Start

September 1, 2003

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

May 3, 2012

Record last verified: 2012-05

Locations