EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan
Congestive Heart Failure
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring chronic heart failure, heart failure
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham
- The Heart Center
- The Heart Group
- Phoenix Memorial Hospital
- Arizona Heart Institute
- Saguaro Clinical Research
- Central Arkansas Veterans Healthcare Systems
- University of Arkansas for Medical Sciences
- Bakersfield Memorial Hospital
- Central Cardiology Medical Center
- Cardiology Associates
- Loma Linda University Medical Center
- LAC/USC Medical Center
- VA Medical Center- W. Los Angeles
- Mission Internal Medical Group
- ARI Clinical Trials
- San Diego Cardiac Center
- Pacific Heart Institute
- Cardiovascular Consultants Medical Group, Inc.
- Aurora Denver Cardiology Associates
- University of Colorado
- Heart and Vascular Clinic of North Colorado
- Bakus Resesarch
- Christiana Care Health System
- VA Medical Center
- Florida Cardiovascular Research
- Cardiology Associates of Fort Lauderdale
- Jacksonville Heart Center
- Jacksonville Heart Center
- Jacksonville Center for Clinical Research
- Melbourne Internal Medicine Assoc.
- University of Miami/ Jackson Memorial Hospital
- Miami Research and Education Foundation
- Ocala Resarch Institute
- Cardiology Research Associates
- Charlotte Heart Group Research Center
- Cardiovascular Center of Sarasota
- The Heart and Vascular Institute of Florida
- Cardiac Disease Specialists PC
- Atlanta Heart and Vascular Research Group
- Georgia Heart Specialists
- Idaho Cardiology Associates
- Idaho Cardiology Associates
- North Shore Cardiologists
- Northwestern University
- Midwest Heart Research Found.
- Illinois Heart & Lung Associates
- Heart Care Midwest
- The Care Group
- Mid America Cardiology
- Cardiovascular Associates
- Louisville Cardiology Medical Group
- The Louisiana Heart Center
- Northshore Medical Research
- Leonard J Chabert Medical Center
- Lousiana State University Health Sciences Center
- Cardiac Centers of LA, LLC
- Androscoggin Cardiology Associates
- Northeast Cardiology Associates
- Maine Medical Center
- MidAtlantic Cardiovascular Associates
- Midatlantic Cardiovascular Associates
- MidAtlantic Cardiovascular Associates
- Midatlantic Cardiovascular Associates
- Shore Health System
- MidAtlantic Cardiovascular Associates
- Heart Associates, P.A.
- MidAtlantic Cardiovascular Associates
- Primary Care Cardiology Research
- Massachusetts General Hospital
- Beth Israel Medical Center
- John Dingell VA Medical Center
- Nisus Research
- William Beaumont Hospital
- Covenant Medical Center
- Beaumont Hospital
- Michigan Heart
- Minneapolis Heart Institute
- Hennepin County Medical Center
- University of Minnesota
- Mayo Clinic, Division of Cardiology
- Park Nicollet Heart Center
- Regions Hospital Cardiology Research
- St. Paul Heart Clinic
- Cardiology Associates of North Mississippi
- Missouri Cardiovascular Specialists
- VA Medical Center- Kansas City
- St. Louis University
- Bryan LGH Heart Institute
- Heart Consultants
- New England Heart Institute
- Morristown Memorial Hospital
- University of Medicine and Dentistry of New Jersey
- Newark Beth Israel Medical Center
- Garden State Cardiology
- Albany Associates in Cardiology
- Cardiology Associates, P.C.
- North Shore University Hospital
- St. Vincents Hospital and Medical Center
- St. Lukes-Roosevelt Hospital Centers
- New York Presbyterian Hospital
- St. Francis Hospital
- SUNY
- South Bay Cardiovascular Associates
- Buffalo Cardiology and Pulmonary Associates
- Asheville Cardiology Associates
- Alamance Regional Medical Center
- University of North Carolina
- Mid Carolina Cardiology
- Durham VA Medical Center
- Duke Cardiology Research
- Pitt County Memorial Hospital, The Heart Center
- Hendersonville Cardiology
- Akron General Medical Center
- Clinical Research Limited
- Sterling Research Group
- The Lindner Clinical Trial Center
- Midwest Cardiology Research Foundation
- The Dayton Heart Center
- Cleveland Cardiovascular Research
- North Ohio Research Limited
- North Ohio Research Limited
- Northwest Ohio Cardiology Consultants
- Integris Heart Research Center
- Oklahoma Cardiovascular Research Group
- Oregon Health and Science University
- Cardiology Consultants of Philadelphia
- The Western Pennsylvania Hospital
- Guthrie Clinic, LTD
- Buxmont Cardiology Associates, PC
- Cardiology Associates of West Reading
- Rhode Island Hospital
- Medical University of South Carolina
- Ralph H. Johnson VAMC
- South Carolina Heart Center
- The Chattanooga Heart Institute
- Cardiovascular Associates
- Baptist Clinical Research Center
- Stern Cardiovascular Center
- Vanderbilt Clinical Trials Center
- The Cardiology Group
- Austin Cardiovascular Associates
- Southeast Texas Cardiology Associates
- Cardiopulmonary Research Science and Technology Institute
- University of Texas Medical Branch
- Cardiology Associates Covenant Medical Group
- McAllen Heart Clinic
- University of Texas Health Science Center
- Wilford Hall Medical Center,
- Scott & White Clinic Division of Cardiology
- VA Salt Lake City Health Care System
- University of Virginia Medical Center
- The Cardiovascular Group PC
- Inova Institute of Research
- Medical College of Virginia
- Cardiovascular Associates of Virginia
- Roanoke Heart Institute
- Empire Health Services
- Rockwood Clinic
- CAMC Clinical Trials
- Wisconsin Center For Clinical Research
- Clinica Constituyentes de Moron
- Clinica Modelo de Moron
- Fundacion Favaloro
- Hospital Argerich
- Hospital Churruca
- Hospital Eva Peron
- Hospital Nacional Dr. Alejandro Posadas
- Hospital de Clinicas
- Hospital Fernandez
- Hospital Italiano de Buenos Aires
- Hospital Privado Antartida
- Hospital Ramos Mejia
- Policlinica Bancaria
- Sanatorio Municipal "Julio A. Mendez"
- Hospital Allende
- Hospital Italiano de Cordoba
- Hospital Militar de Cordoba
- Hospital Privado Centro Medico de Cordoba
- Instituto de Cardiologia J. F. Cabral
- Hospital Central de San Isidro
- AZ Middelheim
- AZ Imelda Ziekenhuis
- Clinique St Elisabeth Place Louise
- Cliniques UCL Mont-Godinne
- Hospital Santa Isabel da Santa Casa de Misericordia da Bahia
- Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos
- Hospital das Clinicas da Universidade Federal de Goias
- Hospital Governador Israel Pinheiro
- Santa Casa de Misericordia de Belo Horizonte
- Hospital Evangelico de Curitiba
- Hospital Nossa Senhora das Gracas
- Santa Casa de Misericordia do Rio de Janeiro
- Irmandade da Santa Casa de Misericordia de Porto Alegre
- Hospital das Clínicas de Porto Alegre
- Hospital Mae de Deus
- Hospital Nossa Senhora da Conceica
- Hospital e Maternidade Celso Pierro
- Hospital de Base da Faculdade de Medicina de Sao Jose do Rio Preto
- IMC- Instituto de Molestias Cardiovasculares
- Instituto do Coracao do Hospital das Clinicas- Faculdade de Medicina da Universidade de Sao Paulo
- Hospital Universitario Onofre Lopes
- Hospital das Clínicas de Porto Alegre
- Hospital Universitario Pedro Ernesto
- Peter Loougheed Center
- Surrey Memorial Hospital
- Victoria Heart Institute Foundation
- St. Boniface General Hospital
- Health Sciences Center
- Brampton Research Associates
- Greater Niagara General Hospital
- Lakeridge Health Oshawa
- Scarborough Cardiology Research
- Cardiology Research Associates
- The Scarborough Hospital
- St. Michael's Hospital
- University Health Network, Toronto Western Hospital
- Centre Hospitalier de l'Universite de Sherbrooke
- CHRDL
- Invascor Clinical Research
- Montreal Heart Institute
- Royal Victoria Hospital
- Montreal General Hospital
- Hotel-Dieu de Saint-Jerome
- I. interni kardio-angiologicka klinika LF MU
- Interni oddeleni
- Interni oddeleni
- Interni klinika, Oddeleni Interna I, Kardiologie
- Interni oddeleni
- I.Interni klinika
- I.Interni oddeleni
- II.Interni klinika
- Kardiologicka klinika
- Kardiologicke oddeleni
- Klinika kardiologie
- Interni oddeleni
- Interni klinika IPVZ
- Centre Hospitalier Regional d'Arras-Service de Cardiologie
- Hopital General Henri Duffaut
- Centre Hospitalier Jeanne d'Arc
- Hopital Louis Pradel
- Cabinet de Cardiologie et d'Explorations
- Centre Hospitalier
- CHU Montpellier
- Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie
- Hopital Pasteur
- Centre Cardiologique du Nord
- Groupe Hospitalier Rangueil-Larrey CHU
- Centre Hospitalier Universitaire de Nancy-Brabois
- Klinikum Augsburg
- Herzzentrum Bad Krozingen
- Herz- und Gefabklinik Bad Neustadt
- Vivantes Klinikum Neukoln
- Akademisches Lehrkrankenhaus d. HGS Essen
- Universitatsklinik Essen
- Georg-August-Universitat Gottingen
- Universitatsklinikum der
- Klinikum der Medizinischen Fakultat
- Universitatsklinikum Eppendorf
- Medizinische Universitätsklinik
- Universitatsklinikum Heidelberg
- Universitatsklinikum des Saarland
- Friedrich Schiller Universitat Jena
- Klinikum der Universitat zu Koln
- University Leipzig
- Universitatsklinikum Munster
- Herz- und Diabetes Zentrum Nordrhein-Westfalen
- Universitat Regensburg
- Marienkrankenhaus Soest
- Robert-Bosch-Krankenhaus
- Ospedale Civile S. Giuseppe
- Azienda Ospedaliera S. Michele
- Ospedale Civile
- Azienda USL n. 6 Ospedale Civile
- Poliambulatorio Valdichiana Ospedale di Cortona
- Centro Cardiologico Monzino
- Ospedale Nigaurda Ca Granda
- Fondazione Salvatore Maugeri
- Presidio Ospedaliero Villa Sofia
- Ospedali Riunti
- IRCCS Policlinico S. Matteo
- IRCCS- Fondazione Salvatore Maugeri
- Ospedale S. Maria delle Grazie
- Ospedale S. Bartolomeo
- Ospedali Civile SS Annunziata
- Sint Lucas Andreas Ziekenhuis (loc. Lucas)
- Gelre Ziekenhuis (location Juliana)
- Ziekenhuis Gooi Noord
- Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG)
- Medisch Centrum Haaglanden (location Westeinde)
- Deventer Ziekenhuis
- Ziekenhuis Gelderse Vallei
- Medisch Spectrum Twente
- Oosterschelde Ziekenhuizen
- Martini Ziekenhuis (Loc. Martini Paviljoen)
- Spaarne Ziekenhuis
- Ziekenhuis Hilversum
- Canisius-Wilhelmina Ziekenhuis
- Isala Klinieken (Loc. Sophia)
- Hjerte med. Avd. Haukeland Universitets Sykehus
- Nordlandsykehuset
- Hjertemed.avd. Akershus Universitetssykenhus
- Diakonhjemmets sykehus Oslo
- Med. Avd. Sykenhuset Telemark
- Stavanger Helseforskning
- Oddzial Kardiologii
- Oddzial Kardiologii
- Oddzial Kardiologii
- Oddzial Chorob Wewnetrznych
- Oddzial Kardiologiczny
- Oddzial Kardiologii
- Oddzial Kardiologiczny
- Oddzial Kardiologiczny
- Oddzial Kardiologii
- Oddzial Kardiologii
- Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii
- I Klinika Choroby Wiencowej
- Katedra i Klinika Chorab Wewnetrznych i Kardiologii
- Oddzial Kardiologii
- Spitalul Judetean Brasov, Sectia de Cardiologie
- Institutul de Boli Cardiovasculare
- Spitalul Caritas, Clinica Medicala
- Spitalul de Urgenta Floreasca, Clinica de Cardiologie
- Spitalul Universitar de Urgenta Bucuresti
- Spitalul Universitar de Urgenta
- Institutul Inimii, Prof.N. Stancioiu
- Centrul de Cardiologie Craiova
- Spitalul Clinic Universitar ,,Sf. Spiridon"
- Spitalul Clinic Judetean Mures
- Institutul de Boli Cardiovasculare Timisoara
- Botkins Moscow City Hospital
- Burdenko Main Military Clinical Hospital
- Cardiology Research Center
- Central Clinical Hospital Presidential
- City Clinical Hospital 2
- Institute of Physico-Chemical Medicine
- Medical Center of General Management
- Moscow Medical Academy
- Moscow Regional Research Clinical Institute n.a. Vishnevsky
- Moscow State University of Medicine and Dentistry - City Hospital #11
- Moscow State University of Medicine and Dentistry - City Hospital #40
- Moscow State University of Medicine and Dentistry
- Russian State Medical University
- Veterans Hospital #3
- Cardiology Research Institute of the Ministry of Health of the Russian Federation
- City Alexandrovsky Hospital, ICU Department
- City Hospital #31
- City Hospital 8
- Military Medical Academy
- St. Elisabeth City Hospital
- St. Petersburg Clinical Hospital of Russian Academy of Sciences
- St. Petersburg Dzanelidze State Scientific Research Institute for Emergency Medical Care
- St. Petersburg Medical Postgraduate Academy
- St. Petersburg State University
- Hospital de Torrecardenas
- Hospital Clinic y Provincial
- Hospital de Cruces
- Hospital Reina Sofia, in Cordoba
- Hospital Doce de Octubre
- Hospital Severo Ochoa
- Hospital Universitari de Tarragona Joan XXIII
- Hospital General Universitario de Valencia
- Medicinkliniken
- Avd. for intermedicin
- Kardiologkliniken
- Kardiologkliniken
- Forskiningsenheten,
- Enheten for internmedicin, Karolinska Institutet
- Hjartkliniken, M84
- Kardiologkliniken
- Hjartcentrum,
- Cardiologkliniken, Avd 50F
- Cardiocentro Ticino
- Bradford Royal Infirmary
- Castle Hill Hospital
- Leeds General Infirmary
- Northern Manchester General Hospital
- Scunthorpe General Hospital