AzTrials
AzTrials

Congestive Heart FailurePhase 3NCT00071331

EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan

A Phase 3 study testing Tolvaptan in people with Congestive Heart Failure, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 378 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
Tolvaptan
How many people
3,600 participants
Where
378 sitesin 18 countries
Study dates
Sep 2003to Jul 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

378 sites in 18 countries.

378 sites in 18 countries

United States161 sites

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Albany Associates in Cardiology

    Albany, New York, 12212

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Cardiac Disease Specialists PC

    Atlanta, Georgia, 30309

  • Atlanta Heart and Vascular Research Group

    Atlanta, Georgia, 30342

  • Florida Cardiovascular Research

    Atlantis, Florida, 33462

  • Androscoggin Cardiology Associates

    Auburn, Maine, 04210

  • Austin Cardiovascular Associates

    Austin, Texas, 78705

  • Primary Care Cardiology Research

    Ayer, Massachusetts, 01432

  • Bakersfield Memorial Hospital

    Bakersfield, California, 93301

  • Central Cardiology Medical Center

    Bakersfield, California, 93301

  • MidAtlantic Cardiovascular Associates

    Baltimore, Maryland, 21218

  • Midatlantic Cardiovascular Associates

    Baltimore, Maryland, 21229

  • MidAtlantic Cardiovascular Associates

    Baltimore, Maryland, 21237

  • Northeast Cardiology Associates

    Bangor, Maine, 04401

  • North Shore Cardiologists

    Bannockburn, Illinois, 60015

  • Southeast Texas Cardiology Associates

    Beaumont, Texas, 77702

  • Midatlantic Cardiovascular Associates

    Bel Air, Maryland, 21014

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Idaho Cardiology Associates

    Boise, Idaho, 83704

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Medical Center

    Boston, Massachusetts, 02215

  • Alamance Regional Medical Center

    Burlington, North Carolina, 27215

  • Clinical Research Limited

    Canton, Ohio, 44718

  • The Louisiana Heart Center

    Chalmette, Louisiana, 70043

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina

    Charleston, South Carolina, 29401

  • Ralph H. Johnson VAMC

    Charleston, South Carolina, 29401

  • CAMC Clinical Trials

    Charleston, West Virginia, 25304

  • Mid Carolina Cardiology

    Charlotte, North Carolina, 28204

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • The Chattanooga Heart Institute

    Chattanooga, Tennessee, 37404

  • Northwestern University

    Chicago, Illinois, 60611

  • Sterling Research Group

    Cincinnati, Ohio, 45219

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • Midwest Cardiology Research Foundation

    Columbus, Ohio, 43214

  • Georgia Heart Specialists

    Covington, Georgia, 30014

  • Northshore Medical Research

    Covington, Louisiana, 70433

  • Cardiopulmonary Research Science and Technology Institute

    Dallas, Texas, 75230

  • The Dayton Heart Center

    Dayton, Ohio, 45414

  • Aurora Denver Cardiology Associates

    Denver, Colorado, 80218

  • University of Colorado

    Denver, Colorado, 80262

  • John Dingell VA Medical Center

    Detroit, Michigan, 48201

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Duke Cardiology Research

    Durham, North Carolina, 27710

  • Shore Health System

    Easton, Maryland, 21601

  • Wisconsin Center For Clinical Research

    Elkhorn, Wisconsin, 53121

  • The Cardiovascular Group PC

    Fairfax, Virginia, 22031

  • Cleveland Cardiovascular Research

    Fairview Park, Ohio, 44126

  • Inova Institute of Research

    Falls Church, Virginia, 22042

  • Heart and Vascular Clinic of North Colorado

    Fort Collins, Colorado, 80528

  • Cardiology Associates of Fort Lauderdale

    Fort Lauderdale, Florida, 33308

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0553

  • Phoenix Memorial Hospital

    Gilbert, Arizona, 85233

  • Pitt County Memorial Hospital, The Heart Center

    Greenville, North Carolina, 28735

  • Hendersonville Cardiology

    Hendersonville, North Carolina, 28739

  • Leonard J Chabert Medical Center

    Houma, Louisiana, 70360

  • The Heart Center

    Huntsville, Alabama, 35801

  • The Care Group

    Indianapolis, Indiana, 46260

  • Jacksonville Heart Center

    Jacksonville, Florida, 32207

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Jacksonville Heart Center

    Jacksonville Beach, Florida, 32250

  • Cardiology Associates, P.C.

    Johnson City, New York, 13790

  • Mid America Cardiology

    Kansas City, Kansas, 66160

  • VA Medical Center- Kansas City

    Kansas City, Missouri, 64128

  • Cardiovascular Associates

    Kingsport, Tennessee, 37660

  • Cardiology Associates

    Larkspur, California, 94939

  • Bryan LGH Heart Institute

    Lincoln, Nebraska, 68516

  • Central Arkansas Veterans Healthcare Systems

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Midwest Heart Research Found.

    Lombard, Illinois, 60148

  • North Ohio Research Limited

    Lorain, Ohio, 44052

  • LAC/USC Medical Center

    Los Angeles, California, 90033

  • VA Medical Center- W. Los Angeles

    Los Angeles, California, 90073

  • Cardiovascular Associates

    Louisville, Kentucky, 40205

  • Louisville Cardiology Medical Group

    Louisville, Kentucky, 40207

  • Cardiology Associates Covenant Medical Group

    Lubbock, Texas, 79410

  • New England Heart Institute

    Manchester, New Hampshire, 03102

  • North Shore University Hospital

    Manhasset, New York, 11030

  • McAllen Heart Clinic

    McAllen, Texas, 78503

  • Melbourne Internal Medicine Assoc.

    Melbourne, Florida, 32901

  • Baptist Clinical Research Center

    Memphis, Tennessee, 38120

  • Stern Cardiovascular Center

    Memphis, Tennessee, 38120

  • Idaho Cardiology Associates

    Meridian, Idaho, 83642

  • University of Miami/ Jackson Memorial Hospital

    Miami, Florida, 33136

  • Miami Research and Education Foundation

    Miami, Florida, 33156

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55416

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mission Internal Medical Group

    Mission Viejo, California, 92691

  • The Heart Group

    Mobile, Alabama, 36608

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962-1956

  • Vanderbilt Clinical Trials Center

    Nashville, Tennessee, 37212

  • St. Vincents Hospital and Medical Center

    New York, New York, 10011

  • St. Lukes-Roosevelt Hospital Centers

    New York, New York, 10019

  • New York Presbyterian Hospital

    New York, New York, 10032

  • Christiana Care Health System

    Newark, Delaware, 19718

  • University of Medicine and Dentistry of New Jersey

    Newark, New Jersey, 07103

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Illinois Heart & Lung Associates

    Normal, Illinois, 61761

  • Bakus Resesarch

    Norwich, Connecticut, 06360

  • Ocala Resarch Institute

    Ocala, Florida, 34480

  • Integris Heart Research Center

    Oklahoma City, Oklahoma, 73112

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

  • Heart Consultants

    Omaha, Nebraska, 68122

  • Cardiology Research Associates

    Ormond Beach, Florida, 32174

  • Garden State Cardiology

    Paramus, New Jersey, 07652

  • Heart Care Midwest

    Peoria, Illinois, 61603

  • Nisus Research

    Petoskey, Michigan, 49770

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19146

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

  • The Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Charlotte Heart Group Research Center

    Port Charlotte, Florida, 33952

  • Maine Medical Center

    Portland, Maine, 04102

  • Oregon Health and Science University

    Portland, Oregon, 97230

  • Rhode Island Hospital

    Providence, Rhode Island, 02905

  • ARI Clinical Trials

    Redondo Beach, California, 92077

  • Medical College of Virginia

    Richmond, Virginia, 23219

  • Cardiovascular Associates of Virginia

    Richmond, Virginia, 23225

  • Roanoke Heart Institute

    Roanoke, Virginia, 24014

  • Mayo Clinic, Division of Cardiology

    Rochester, Minnesota, 55905

  • St. Francis Hospital

    Roslyn, New York, 11576

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-1026

  • Covenant Medical Center

    Saginaw, Michigan, 48602

  • Park Nicollet Heart Center

    Saint Louis Park, Minnesota, 55426

  • Regions Hospital Cardiology Research

    Saint Paul, Minnesota, 55101

  • St. Paul Heart Clinic

    Saint Paul, Minnesota, 55102

  • VA Salt Lake City Health Care System

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center

    San Antonio, Texas, 78229-3900

  • Wilford Hall Medical Center,

    San Antonio, Texas, 78236

  • San Diego Cardiac Center

    San Diego, California, 92123

  • North Ohio Research Limited

    Sandusky, Ohio, 44870

  • Pacific Heart Institute

    Santa Monica, California, 90404

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239

  • Guthrie Clinic, LTD

    Sayre, Pennsylvania, 18840

  • Buxmont Cardiology Associates, PC

    Sellersville, Pennsylvania, 18960

  • Lousiana State University Health Sciences Center

    Shreveport, Louisiana, 71103

  • Cardiac Centers of LA, LLC

    Shreveport, Louisiana, 71135

  • Empire Health Services

    Spokane, Washington, 99204

  • Rockwood Clinic

    Spokane, Washington, 99204

  • St. Louis University

    St Louis, Missouri, 63110

  • The Heart and Vascular Institute of Florida

    St. Petersburg, Florida, 33701

  • SUNY

    Syracuse, New York, 13230

  • Scott & White Clinic Division of Cardiology

    Temple, Texas, 76508

  • Northwest Ohio Cardiology Consultants

    Toledo, Ohio, 43615

  • MidAtlantic Cardiovascular Associates

    Towson, Maryland, 21204

  • Heart Associates, P.A.

    Towson, Maryland, 21286

  • Beaumont Hospital

    Troy, Michigan, 48085

  • Saguaro Clinical Research

    Tucson, Arizona, 85712

  • The Cardiology Group

    Tullahoma, Tennessee, 37388

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi, 38801

  • Cardiovascular Consultants Medical Group, Inc.

    Walnut Creek, California, 94598

  • VA Medical Center

    Washington D.C., District of Columbia, 20422

  • South Bay Cardiovascular Associates

    West Islip, New York, 11795

  • Cardiology Associates of West Reading

    West Reading, Pennsylvania, 19611

  • MidAtlantic Cardiovascular Associates

    Westminster, Maryland, 21157

  • Buffalo Cardiology and Pulmonary Associates

    Williamsville, New York, 14221

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Russia24 sites

  • Botkins Moscow City Hospital

    Moscow

  • Burdenko Main Military Clinical Hospital

    Moscow

  • Cardiology Research Center

    Moscow

  • Central Clinical Hospital Presidential

    Moscow

  • City Clinical Hospital 2

    Moscow

  • Institute of Physico-Chemical Medicine

    Moscow

  • Medical Center of General Management

    Moscow

  • Moscow Medical Academy

    Moscow

  • Moscow Regional Research Clinical Institute n.a. Vishnevsky

    Moscow

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

    Moscow

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

    Moscow

  • Moscow State University of Medicine and Dentistry

    Moscow

  • Russian State Medical University

    Moscow

  • Veterans Hospital #3

    Moscow

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

    Saint Petersburg

  • City Alexandrovsky Hospital, ICU Department

    Saint Petersburg

  • City Hospital #31

    Saint Petersburg

  • City Hospital 8

    Saint Petersburg

  • Military Medical Academy

    Saint Petersburg

  • St. Elisabeth City Hospital

    Saint Petersburg

  • St. Petersburg Clinical Hospital of Russian Academy of Sciences

    Saint Petersburg

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

    Saint Petersburg

  • St. Petersburg Medical Postgraduate Academy

    Saint Petersburg

  • St. Petersburg State University

    Saint Petersburg

Other trials in Russia

Germany21 sites

  • Klinikum Augsburg

    Augsburg

  • Herzzentrum Bad Krozingen

    Bad Krozingen

  • Herz- und Gefabklinik Bad Neustadt

    Bad Neustadt-Saale

  • Vivantes Klinikum Neukoln

    Berlin

  • Klinikum der Universitat zu Koln

    Cologne

  • Akademisches Lehrkrankenhaus d. HGS Essen

    Essen

  • Universitatsklinik Essen

    Essen

  • Georg-August-Universitat Gottingen

    Göttingen

  • Universitatsklinikum der

    Greifswald

  • Klinikum der Medizinischen Fakultat

    Halle

  • Universitatsklinikum Eppendorf

    Hamburg

  • Medizinische Universitätsklinik

    Heidelberg

  • Universitatsklinikum Heidelberg

    Heidelberg

  • Universitatsklinikum des Saarland

    Homburg/Saar

  • Friedrich Schiller Universitat Jena

    Jena

  • University Leipzig

    Leipzig

  • Universitatsklinikum Munster

    Münster

  • Herz- und Diabetes Zentrum Nordrhein-Westfalen

    Oeyenhausen

  • Universitat Regensburg

    Regensburg

  • Marienkrankenhaus Soest

    Soest

  • Robert-Bosch-Krankenhaus

    Stuttgart

Other trials in Germany

Argentina20 sites

  • Clinica Constituyentes de Moron

    Buenos Aires

  • Clinica Modelo de Moron

    Buenos Aires

  • Fundacion Favaloro

    Buenos Aires

  • Hospital Argerich

    Buenos Aires

  • Hospital Churruca

    Buenos Aires

  • Hospital Eva Peron

    Buenos Aires

  • Hospital Nacional Dr. Alejandro Posadas

    Buenos Aires

  • Hospital de Clinicas

    Capital Federal

  • Hospital Fernandez

    Capital Federal

  • Hospital Italiano de Buenos Aires

    Capital Federal

  • Hospital Privado Antartida

    Capital Federal

  • Hospital Ramos Mejia

    Capital Federal

  • Policlinica Bancaria

    Capital Federal

  • Sanatorio Municipal "Julio A. Mendez"

    Capital Federal

  • Hospital Allende

    Córdoba

  • Hospital Italiano de Cordoba

    Córdoba

  • Hospital Militar de Cordoba

    Córdoba

  • Hospital Privado Centro Medico de Cordoba

    Córdoba

  • Instituto de Cardiologia J. F. Cabral

    Corrientes

  • Hospital Central de San Isidro

    San Isidro

Other trials in Argentina

Canada20 sites

  • Brampton Research Associates

    Brampton, Ontario, L6V1B4

  • Peter Loougheed Center

    Calgary, Alberta, T1Y6J4

  • Centre Hospitalier de l'Universite de Sherbrooke

    Fleurimond, Quebec, J1H 5N4

  • CHRDL

    Joliette, Quebec, J6E6J2

  • Invascor Clinical Research

    Longueuil, Quebec, J4M 1E1

  • Montreal Heart Institute

    Montreal, Quebec, H1T1C8

  • Royal Victoria Hospital

    Montreal, Quebec, H3A1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Greater Niagara General Hospital

    Niagara Falls, Ontario, L2E6Y2

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G2B9

  • Hotel-Dieu de Saint-Jerome

    Saint-Jérôme, Quebec, J7Z 5T3

  • Scarborough Cardiology Research

    Scarborough Village, Ontario, M1E5E9

  • Cardiology Research Associates

    Scarborough Village, Ontario, M2S4V5

  • Health Sciences Center

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

  • Surrey Memorial Hospital

    Surrey, British Columbia, V3V1Z2

  • The Scarborough Hospital

    Toronto, Ontario, M1P 2V5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • University Health Network, Toronto Western Hospital

    Toronto, Ontario, M5G 2C4

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R4R2

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Brazil19 sites

  • Hospital Governador Israel Pinheiro

    Belo Horizonte, Minas Gerais, 30130-110

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital e Maternidade Celso Pierro

    Campinas, São Paulo, 13059-740

  • Hospital Evangelico de Curitiba

    Curitiba, Paraná, 80730-150

  • Hospital Nossa Senhora das Gracas

    Curitiba, Paraná, 80810-040

  • Hospital das Clinicas da Universidade Federal de Goias

    Goiânia, Goiás, 74605-050

  • Hospital Universitario Onofre Lopes

    Natal, 59012-310

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital das Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90880-480

  • Hospital Nossa Senhora da Conceica

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital das Clínicas de Porto Alegre

    Porto Alegre, 90035-003

  • Santa Casa de Misericordia do Rio de Janeiro

    Rio de Janeiro, Rio de Janeiro, 20020-020

  • Hospital Universitario Pedro Ernesto

    Rio de Janeiro, 20551-030

  • Hospital Santa Isabel da Santa Casa de Misericordia da Bahia

    Salvador, Estado de Bahia, 40050-410

  • Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos

    Salvador, Estado de Bahia, 40140-060

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

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

  • IMC- Instituto de Molestias Cardiovasculares

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

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

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Italy15 sites

  • Ospedale Civile S. Giuseppe

    Albano Laziale

  • Azienda Ospedaliera S. Michele

    Cagliari

  • Ospedale Civile

    Capri city

  • Azienda USL n. 6 Ospedale Civile

    Cecina

  • Poliambulatorio Valdichiana Ospedale di Cortona

    Cortona

  • Centro Cardiologico Monzino

    Milan

  • Ospedale Nigaurda Ca Granda

    Milan

  • Fondazione Salvatore Maugeri

    Montescano

  • Presidio Ospedaliero Villa Sofia

    Palmero

  • Ospedali Riunti

    Parma

  • IRCCS Policlinico S. Matteo

    Pavia

  • IRCCS- Fondazione Salvatore Maugeri

    Pavia

  • Ospedale S. Maria delle Grazie

    Pozzuoli

  • Ospedale S. Bartolomeo

    Sarzana

  • Ospedali Civile SS Annunziata

    Sassari

Other trials in Italy

Netherlands14 sites

  • Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG)

    's-Hertogenbosch

  • Sint Lucas Andreas Ziekenhuis (loc. Lucas)

    Amsterdam

  • Gelre Ziekenhuis (location Juliana)

    Apeldoorn

  • Ziekenhuis Gooi Noord

    Blaricum

  • Deventer Ziekenhuis

    Deventer

  • Ziekenhuis Gelderse Vallei

    Ede

  • Medisch Spectrum Twente

    Enschede

  • Oosterschelde Ziekenhuizen

    Goes

  • Martini Ziekenhuis (Loc. Martini Paviljoen)

    Groningen

  • Spaarne Ziekenhuis

    Heemstede

  • Ziekenhuis Hilversum

    Hilversum

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen

  • Medisch Centrum Haaglanden (location Westeinde)

    The Hague

  • Isala Klinieken (Loc. Sophia)

    Zwolle

Other trials in Netherlands

Poland14 sites

  • Oddzial Kardiologii

    Bydgoszcz

  • Oddzial Kardiologii

    Krakow

  • Oddzial Kardiologii

    Lodz

  • Oddzial Chorob Wewnetrznych

    Oława

  • Oddzial Kardiologiczny

    Opole

  • Oddzial Kardiologii

    Ostrowiec Świętokrzyski

  • Oddzial Kardiologiczny

    Piotrkow Trybunalski

  • Oddzial Kardiologiczny

    Płock

  • Oddzial Kardiologii

    Sieradz

  • Oddzial Kardiologii

    Torun

  • Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii

    Tychy

  • I Klinika Choroby Wiencowej

    Warsaw

  • Katedra i Klinika Chorab Wewnetrznych i Kardiologii

    Warsaw

  • Oddzial Kardiologii

    Włocławek

Other trials in Poland

Czechia13 sites

  • I. interni kardio-angiologicka klinika LF MU

    Brno

  • Interni oddeleni

    Jablonec nad Nisou

  • Interni oddeleni

    Náchod

  • Interni klinika, Oddeleni Interna I, Kardiologie

    Pardubice

  • Interni oddeleni

    Písek

  • I.Interni klinika

    Plzen-Lochotin

  • I.Interni oddeleni

    Prague

  • II.Interni klinika

    Prague

  • Kardiologicka klinika

    Prague

  • Kardiologicke oddeleni

    Prague

  • Klinika kardiologie

    Prague

  • Interni oddeleni

    Ústí nad Labem

  • Interni klinika IPVZ

    Zlín

Other trials in Czechia

France12 sites

  • Centre Hospitalier Regional d'Arras-Service de Cardiologie

    Arras

  • Hopital General Henri Duffaut

    Avignon

  • Centre Hospitalier Jeanne d'Arc

    Bar-le-Duc

  • Hopital Louis Pradel

    Bron

  • Cabinet de Cardiologie et d'Explorations

    Essey-lès-Nancy

  • Centre Hospitalier

    Langres

  • CHU Montpellier

    Montpellier

  • Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie

    Nantes, 44093

  • Hopital Pasteur

    Nice

  • Centre Cardiologique du Nord

    Saint-Denis

  • Groupe Hospitalier Rangueil-Larrey CHU

    Toulouse, 31403

  • Centre Hospitalier Universitaire de Nancy-Brabois

    Vandœuvre-lès-Nancy

Other trials in France

Romania11 sites

  • Spitalul Judetean Brasov, Sectia de Cardiologie

    Brasov

  • Institutul de Boli Cardiovasculare

    Bucharest

  • Spitalul Caritas, Clinica Medicala

    Bucharest

  • Spitalul de Urgenta Floreasca, Clinica de Cardiologie

    Bucharest

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest

  • Spitalul Universitar de Urgenta

    Bucharest

  • Institutul Inimii, Prof.N. Stancioiu

    Cluj-Napoca

  • Centrul de Cardiologie Craiova

    Craiova

  • Spitalul Clinic Universitar ,,Sf. Spiridon"

    Iași

  • Spitalul Clinic Judetean Mures

    Târgu Mureş

  • Institutul de Boli Cardiovasculare Timisoara

    Timișoara

Other trials in Romania

Sweden10 sites

  • Avd. for intermedicin

    Gothenburg

  • Medicinkliniken

    Gothenburg

  • Kardiologkliniken

    Linköping

  • Kardiologkliniken

    Malmö

  • Forskiningsenheten,

    Mölndal

  • Enheten for internmedicin, Karolinska Institutet

    Stockholm

  • Hjartkliniken, M84

    Stockholm

  • Kardiologkliniken

    Stockholm

  • Hjartcentrum,

    Umeå

  • Cardiologkliniken, Avd 50F

    Uppsala

Other trials in Sweden

Spain8 sites

  • Hospital de Torrecardenas

    Almería

  • Hospital Clinic y Provincial

    Barcelona

  • Hospital de Cruces

    Bilbao

  • Hospital Reina Sofia, in Cordoba

    Córdoba

  • Hospital Doce de Octubre

    Madrid

  • Hospital Severo Ochoa

    Madrid

  • Hospital Universitari de Tarragona Joan XXIII

    Tarragona

  • Hospital General Universitario de Valencia

    Valencia

Other trials in Spain

Norway6 sites

  • Hjerte med. Avd. Haukeland Universitets Sykehus

    Bergen

  • Nordlandsykehuset

    Bodø

  • Hjertemed.avd. Akershus Universitetssykenhus

    Nordbyhagen

  • Diakonhjemmets sykehus Oslo

    Oslo

  • Med. Avd. Sykenhuset Telemark

    Skien

  • Stavanger Helseforskning

    Stavanger

Other trials in Norway

United Kingdom5 sites

  • Bradford Royal Infirmary

    Bradford

  • Castle Hill Hospital

    Cottingham

  • Leeds General Infirmary

    Leeds

  • Northern Manchester General Hospital

    Manchester

  • Scunthorpe General Hospital

    Scunthorpe

Other trials in United Kingdom

Belgium4 sites

  • AZ Middelheim

    Antwerp

  • AZ Imelda Ziekenhuis

    Bonheiden

  • Clinique St Elisabeth Place Louise

    Namur

  • Cliniques UCL Mont-Godinne

    Yvoir

Other trials in Belgium

Switzerland1 site

  • Cardiocentro Ticino

    Lugano

Other trials in Switzerland

About this study

Official title: Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure

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

Read the detailed description

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

Being tested
Tolvaptan
Keywords
chronic heart failure, heart failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TolvaptanDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
3,600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00071331
Sponsor's protocol ID
156-03-236
Status last verified
May 2012
First submitted
20 Oct 2003
Last updated
3 May 2012
Results posted
No

Publications

  • 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.

    PubMed 40643971

  • 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.

    PubMed 34465123

  • 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.

    PubMed 27266853

  • 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.

    PubMed 27140204

  • 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.

    PubMed 24737459

  • 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.

    PubMed 23743487

  • 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.

    PubMed 23351825

  • 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.

    PubMed 21693723

  • 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.

    PubMed 20435194

  • 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.

    PubMed 18992654

  • 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.

    PubMed 17384438

  • 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.

    PubMed 17384437

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tolvaptan in people with Congestive Heart Failure, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 378 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 378 sites in United States, Russia, Germany, Argentina, Canada and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00071331, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.

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