Clinical trial NCT00071331: EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Congestive Heart Failure
Keywords: chronic heart failure
heart failure
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2003-10-21
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: The Heart Center
state: Alabama
city: Mobile
country: United States
facility: The Heart Group
state: Alabama
city: Gilbert
country: United States
facility: Phoenix Memorial Hospital
state: Arizona
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Tucson
country: United States
facility: Saguaro Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare Systems
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: Bakersfield
country: United States
facility: Central Cardiology Medical Center
state: California
city: Larkspur
country: United States
facility: Cardiology Associates
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: LAC/USC Medical Center
state: California
city: Los Angeles
country: United States
facility: VA Medical Center- W. Los Angeles
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: Redondo Beach
country: United States
facility: ARI Clinical Trials
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Walnut Creek
country: United States
facility: Cardiovascular Consultants Medical Group, Inc.
state: California
city: Denver
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Fort Collins
country: United States
facility: Heart and Vascular Clinic of North Colorado
state: Colorado
city: Norwich
country: United States
facility: Bakus Resesarch
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Washington
country: United States
facility: VA Medical Center
state: District of Columbia
city: Atlantis
country: United States
facility: Florida Cardiovascular Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Cardiology Associates of Fort Lauderdale
state: Florida
city: Jacksonville Beach
country: United States
facility: Jacksonville Heart Center
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Heart Center
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Assoc.
state: Florida
city: Miami
country: United States
facility: University of Miami/ Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Miami Research and Education Foundation
state: Florida
city: Ocala
country: United States
facility: Ocala Resarch Institute
state: Florida
city: Ormond Beach
country: United States
facility: Cardiology Research Associates
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart Group Research Center
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: St. Petersburg
country: United States
facility: The Heart and Vascular Institute of Florida
state: Florida
city: Atlanta
country: United States
facility: Cardiac Disease Specialists PC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Heart and Vascular Research Group
state: Georgia
city: Covington
country: United States
facility: Georgia Heart Specialists
state: Georgia
city: Boise
country: United States
facility: Idaho Cardiology Associates
state: Idaho
city: Meridian
country: United States
facility: Idaho Cardiology Associates
state: Idaho
city: Bannockburn
country: United States
facility: North Shore Cardiologists
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Lombard
country: United States
facility: Midwest Heart Research Found.
state: Illinois
city: Normal
country: United States
facility: Illinois Heart & Lung Associates
state: Illinois
city: Peoria
country: United States
facility: Heart Care Midwest
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: Kansas City
country: United States
facility: Mid America Cardiology
state: Kansas
city: Louisville
country: United States
facility: Cardiovascular Associates
state: Kentucky
city: Louisville
country: United States
facility: Louisville Cardiology Medical Group
state: Kentucky
city: Chalmette
country: United States
facility: The Louisiana Heart Center
state: Louisiana
city: Covington
country: United States
facility: Northshore Medical Research
state: Louisiana
city: Houma
country: United States
facility: Leonard J Chabert Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Lousiana State University Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: Cardiac Centers of LA, LLC
state: Louisiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates
state: Maine
city: Bangor
country: United States
facility: Northeast Cardiology Associates
state: Maine
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: MidAtlantic Cardiovascular Associates
state: Maryland
city: Baltimore
country: United States
facility: Midatlantic Cardiovascular Associates
state: Maryland
city: Baltimore
country: United States
facility: MidAtlantic Cardiovascular Associates
state: Maryland
city: Bel Air
country: United States
facility: Midatlantic Cardiovascular Associates
state: Maryland
city: Easton
country: United States
facility: Shore Health System
state: Maryland
city: Towson
country: United States
facility: MidAtlantic Cardiovascular Associates
state: Maryland
city: Towson
country: United States
facility: Heart Associates, P.A.
state: Maryland
city: Westminster
country: United States
facility: MidAtlantic Cardiovascular Associates
state: Maryland
city: Ayer
country: United States
facility: Primary Care Cardiology Research
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: John Dingell VA Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Nisus Research
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: Troy
country: United States
facility: Beaumont Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic, Division of Cardiology
state: Minnesota
city: St. Louis Park
country: United States
facility: Park Nicollet Heart Center
state: Minnesota
city: St. Paul
country: United States
facility: Regions Hospital Cardiology Research
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Heart Clinic
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists
state: Missouri
city: Kansas City
country: United States
facility: VA Medical Center- Kansas City
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Omaha
country: United States
facility: Heart Consultants
state: Nebraska
city: Manchester
country: United States
facility: New England Heart Institute
state: New Hampshire
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Paramus
country: United States
facility: Garden State Cardiology
state: New Jersey
city: Albany
country: United States
facility: Albany Associates in Cardiology
state: New York
city: Johnson City
country: United States
facility: Cardiology Associates, P.C.
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: St. Vincents Hospital and Medical Center
state: New York
city: New York
country: United States
facility: St. Lukes-Roosevelt Hospital Centers
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY
state: New York
city: West Islip
country: United States
facility: South Bay Cardiovascular Associates
state: New York
city: Williamsville
country: United States
facility: Buffalo Cardiology and Pulmonary Associates
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Burlington
country: United States
facility: Alamance Regional Medical Center
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke Cardiology Research
state: North Carolina
city: Greenville
country: United States
facility: Pitt County Memorial Hospital, The Heart Center
state: North Carolina
city: Hendersonville
country: United States
facility: Hendersonville Cardiology
state: North Carolina
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Canton
country: United States
facility: Clinical Research Limited
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Columbus
country: United States
facility: Midwest Cardiology Research Foundation
state: Ohio
city: Dayton
country: United States
facility: The Dayton Heart Center
state: Ohio
city: Fairview Park
country: United States
facility: Cleveland Cardiovascular Research
state: Ohio
city: Lorain
country: United States
facility: North Ohio Research Limited
state: Ohio
city: Sandusky
country: United States
facility: North Ohio Research Limited
state: Ohio
city: Toledo
country: United States
facility: Northwest Ohio Cardiology Consultants
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Heart Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic, LTD
state: Pennsylvania
city: Sellersville
country: United States
facility: Buxmont Cardiology Associates, PC
state: Pennsylvania
city: West Reading
country: United States
facility: Cardiology Associates of West Reading
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Ralph H. Johnson VAMC
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Chattanooga
country: United States
facility: The Chattanooga Heart Institute
state: Tennessee
city: Kingsport
country: United States
facility: Cardiovascular Associates
state: Tennessee
city: Memphis
country: United States
facility: Baptist Clinical Research Center
state: Tennessee
city: Memphis
country: United States
facility: Stern Cardiovascular Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Clinical Trials Center
state: Tennessee
city: Tullahoma
country: United States
facility: The Cardiology Group
state: Tennessee
city: Austin
country: United States
facility: Austin Cardiovascular Associates
state: Texas
city: Beaumont
country: United States
facility: Southeast Texas Cardiology Associates
state: Texas
city: Dallas
country: United States
facility: Cardiopulmonary Research Science and Technology Institute
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Lubbock
country: United States
facility: Cardiology Associates Covenant Medical Group
state: Texas
city: McAllen
country: United States
facility: McAllen Heart Clinic
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Medical Center,
state: Texas
city: Temple
country: United States
facility: Scott & White Clinic Division of Cardiology
state: Texas
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Fairfax
country: United States
facility: The Cardiovascular Group PC
state: Virginia
city: Falls Church
country: United States
facility: Inova Institute of Research
state: Virginia
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
city: Richmond
country: United States
facility: Cardiovascular Associates of Virginia
state: Virginia
city: Roanoke
country: United States
facility: Roanoke Heart Institute
state: Virginia
city: Spokane
country: United States
facility: Empire Health Services
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials
state: West Virginia
city: Elkhorn
country: United States
facility: Wisconsin Center For Clinical Research
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Clinica Constituyentes de Moron
city: Buenos Aires
country: Argentina
facility: Clinica Modelo de Moron
city: Buenos Aires
country: Argentina
facility: Fundacion Favaloro
city: Buenos Aires
country: Argentina
facility: Hospital Argerich
city: Buenos Aires
country: Argentina
facility: Hospital Churruca
city: Buenos Aires
country: Argentina
facility: Hospital Eva Peron
city: Buenos Aires
country: Argentina
facility: Hospital Nacional Dr. Alejandro Posadas
city: Capital Federal
country: Argentina
facility: Hospital de Clinicas
city: Capital Federal
country: Argentina
facility: Hospital Fernandez
city: Capital Federal
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Capital Federal
country: Argentina
facility: Hospital Privado Antartida
city: Capital Federal
country: Argentina
facility: Hospital Ramos Mejia
city: Capital Federal
country: Argentina
facility: Policlinica Bancaria
city: Capital Federal
country: Argentina
facility: Sanatorio Municipal "Julio A. Mendez"
city: Cordoba
country: Argentina
facility: Hospital Allende
city: Cordoba
country: Argentina
facility: Hospital Italiano de Cordoba
city: Cordoba
country: Argentina
facility: Hospital Militar de Cordoba
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia J. F. Cabral
city: San Isidro
country: Argentina
facility: Hospital Central de San Isidro
city: Antwerpen
country: Belgium
facility: AZ Middelheim
city: Bonheiden
country: Belgium
facility: AZ Imelda Ziekenhuis
city: Namur
country: Belgium
facility: Clinique St Elisabeth Place Louise
city: Yvoir
country: Belgium
facility: Cliniques UCL Mont-Godinne
city: Salvador
country: Brazil
facility: Hospital Santa Isabel da Santa Casa de Misericordia da Bahia
state: BA
city: Salvador
country: Brazil
facility: Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos
state: BA
city: Goiania
country: Brazil
facility: Hospital das Clinicas da Universidade Federal de Goias
state: GO
city: Belo Horizonte
country: Brazil
facility: Hospital Governador Israel Pinheiro
state: MG
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
state: MG
city: Curitiba
country: Brazil
facility: Hospital Evangelico de Curitiba
state: PR
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Gracas
state: PR
city: Rio de Janeiro
country: Brazil
facility: Santa Casa de Misericordia do Rio de Janeiro
state: RJ
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clínicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceica
state: RS
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro
state: SP
city: Sao Jose de Rio Preto
country: Brazil
facility: Hospital de Base da Faculdade de Medicina de Sao Jose do Rio Preto
state: SP
city: Sao Jose do Rio Preto
country: Brazil
facility: IMC- Instituto de Molestias Cardiovasculares
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao do Hospital das Clinicas- Faculdade de Medicina da Universidade de Sao Paulo
state: SP
city: Natal
country: Brazil
facility: Hospital Universitario Onofre Lopes
city: Porto Alegre
country: Brazil
facility: Hospital das Clínicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Pedro Ernesto
city: Calgary
country: Canada
facility: Peter Loougheed Center
state: Alberta
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: St. John's
country: Canada
facility: Health Sciences Center
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Brampton Research Associates
state: Ontario
city: Niagara Falls
country: Canada
facility: Greater Niagara General Hospital
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Cardiology Research
state: Ontario
city: Scarborough
country: Canada
facility: Cardiology Research Associates
state: Ontario
city: Toronto
country: Canada
facility: The Scarborough Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Toronto Western Hospital
state: Ontario
city: Fleurimond
country: Canada
facility: Centre Hospitalier de l'Universite de Sherbrooke
state: Quebec
city: Joliette
country: Canada
facility: CHRDL
state: Quebec
city: Longueuil
country: Canada
facility: Invascor Clinical Research
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Saint Jerome
country: Canada
facility: Hotel-Dieu de Saint-Jerome
state: Quebec
city: Brno
country: Czech Republic
facility: I. interni kardio-angiologicka klinika LF MU
city: Jablonec nad Nisou
country: Czech Republic
facility: Interni oddeleni
city: Nachod
country: Czech Republic
facility: Interni oddeleni
city: Pardubice
country: Czech Republic
facility: Interni klinika, Oddeleni Interna I, Kardiologie
city: Pisek
country: Czech Republic
facility: Interni oddeleni
city: Plzen-Lochotin
country: Czech Republic
facility: I.Interni klinika
city: Praha
country: Czech Republic
facility: I.Interni oddeleni
city: Praha
country: Czech Republic
facility: II.Interni klinika
city: Praha
country: Czech Republic
facility: Kardiologicka klinika
city: Praha
country: Czech Republic
facility: Kardiologicke oddeleni
city: Praha
country: Czech Republic
facility: Klinika kardiologie
city: Usti nad Labem
country: Czech Republic
facility: Interni oddeleni
city: Zlin
country: Czech Republic
facility: Interni klinika IPVZ
city: Arras
country: France
facility: Centre Hospitalier Regional d'Arras-Service de Cardiologie
city: Avignon
country: France
facility: Hopital General Henri Duffaut
city: Bar-le-Duc
country: France
facility: Centre Hospitalier Jeanne d'Arc
city: Bron cedex
country: France
facility: Hopital Louis Pradel
city: Essey lès Nancy Cedex
country: France
facility: Cabinet de Cardiologie et d'Explorations
city: Langres
country: France
facility: Centre Hospitalier
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes Cedex
country: France
facility: Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie
city: Nice
country: France
facility: Hopital Pasteur
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Toulouse
country: France
facility: Groupe Hospitalier Rangueil-Larrey CHU
city: Vandoeuvre les Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy-Brabois
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Neustadt-Saale
country: Germany
facility: Herz- und Gefabklinik Bad Neustadt
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukoln
city: Essen
country: Germany
facility: Akademisches Lehrkrankenhaus d. HGS Essen
city: Essen
country: Germany
facility: Universitatsklinik Essen
city: Gottingen
country: Germany
facility: Georg-August-Universitat Gottingen
city: Greifswald
country: Germany
facility: Universitatsklinikum der
city: Halle
country: Germany
facility: Klinikum der Medizinischen Fakultat
city: Hamburg
country: Germany
facility: Universitatsklinikum Eppendorf
city: Heidelberg
country: Germany
facility: Medizinische Universitätsklinik
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Homburg/Saar
country: Germany
facility: Universitatsklinikum des Saarland
city: Jena
country: Germany
facility: Friedrich Schiller Universitat Jena
city: Koln
country: Germany
facility: Klinikum der Universitat zu Koln
city: Leipzig
country: Germany
facility: University Leipzig
city: Munster
country: Germany
facility: Universitatsklinikum Munster
city: Oeyenhausen
country: Germany
facility: Herz- und Diabetes Zentrum Nordrhein-Westfalen
city: Regensburg
country: Germany
facility: Universitat Regensburg
city: Soest
country: Germany
facility: Marienkrankenhaus Soest
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Albano Laziale
country: Italy
facility: Ospedale Civile S. Giuseppe
city: Cagliari
country: Italy
facility: Azienda Ospedaliera S. Michele
city: Capri
country: Italy
facility: Ospedale Civile
city: Cecina
country: Italy
facility: Azienda USL n. 6 Ospedale Civile
city: Cortona
country: Italy
facility: Poliambulatorio Valdichiana Ospedale di Cortona
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Milano
country: Italy
facility: Ospedale Nigaurda Ca Granda
city: Montescano
country: Italy
facility: Fondazione Salvatore Maugeri
city: Palmero
country: Italy
facility: Presidio Ospedaliero Villa Sofia
city: Parma
country: Italy
facility: Ospedali Riunti
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
city: Pavia
country: Italy
facility: IRCCS- Fondazione Salvatore Maugeri
city: Pozzuoli
country: Italy
facility: Ospedale S. Maria delle Grazie
city: Sarzana
country: Italy
facility: Ospedale S. Bartolomeo
city: Sassari
country: Italy
facility: Ospedali Civile SS Annunziata
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis (loc. Lucas)
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis (location Juliana)
city: Blaricum
country: Netherlands
facility: Ziekenhuis Gooi Noord
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG)
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden (location Westeinde)
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Goes
country: Netherlands
facility: Oosterschelde Ziekenhuizen
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis (Loc. Martini Paviljoen)
city: Heemstede
country: Netherlands
facility: Spaarne Ziekenhuis
city: Hilversum
country: Netherlands
facility: Ziekenhuis Hilversum
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken (Loc. Sophia)
city: Bergen
country: Norway
facility: Hjerte med. Avd. Haukeland Universitets Sykehus
city: Bodo
country: Norway
facility: Nordlandsykehuset
city: Nordbyhagen
country: Norway
facility: Hjertemed.avd. Akershus Universitetssykenhus
city: Oslo
country: Norway
facility: Diakonhjemmets sykehus Oslo
city: Skien
country: Norway
facility: Med. Avd. Sykenhuset Telemark
city: Stavanger
country: Norway
facility: Stavanger Helseforskning
city: Bydgoszcz
country: Poland
facility: Oddzial Kardiologii
city: Krakow
country: Poland
facility: Oddzial Kardiologii
city: Lodz
country: Poland
facility: Oddzial Kardiologii
city: Olawa
country: Poland
facility: Oddzial Chorob Wewnetrznych
city: Opole
country: Poland
facility: Oddzial Kardiologiczny
city: Ostrowiec Swietokrzyski
country: Poland
facility: Oddzial Kardiologii
city: Piotrków Trybunalski
country: Poland
facility: Oddzial Kardiologiczny
city: Plock
country: Poland
facility: Oddzial Kardiologiczny
city: Sieradz
country: Poland
facility: Oddzial Kardiologii
city: Torun
country: Poland
facility: Oddzial Kardiologii
city: Tychy
country: Poland
facility: Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii
city: Warszawa
country: Poland
facility: I Klinika Choroby Wiencowej
city: Warszawa
country: Poland
facility: Katedra i Klinika Chorab Wewnetrznych i Kardiologii
city: Wloclawek
country: Poland
facility: Oddzial Kardiologii
city: Brasov
country: Romania
facility: Spitalul Judetean Brasov, Sectia de Cardiologie
city: Bucharest
country: Romania
facility: Institutul de Boli Cardiovasculare
city: Bucharest
country: Romania
facility: Spitalul Caritas, Clinica Medicala
city: Bucharest
country: Romania
facility: Spitalul de Urgenta Floreasca, Clinica de Cardiologie
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta
city: Cluj-Napoca
country: Romania
facility: Institutul Inimii, Prof.N. Stancioiu
city: Craiova
country: Romania
facility: Centrul de Cardiologie Craiova
city: Iasi
country: Romania
facility: Spitalul Clinic Universitar ,,Sf. Spiridon"
city: Targu-Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Timisoara
country: Romania
facility: Institutul de Boli Cardiovasculare Timisoara
city: Moscow
country: Russian Federation
facility: Botkins Moscow City Hospital
city: Moscow
country: Russian Federation
facility: Burdenko Main Military Clinical Hospital
city: Moscow
country: Russian Federation
facility: Cardiology Research Center
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital Presidential
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 2
city: Moscow
country: Russian Federation
facility: Institute of Physico-Chemical Medicine
city: Moscow
country: Russian Federation
facility: Medical Center of General Management
city: Moscow
country: Russian Federation
facility: Moscow Medical Academy
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute n.a. Vishnevsky
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry - City Hospital #11
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry - City Hospital #40
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
city: Moscow
country: Russian Federation
facility: Russian State Medical University
city: Moscow
country: Russian Federation
facility: Veterans Hospital #3
city: St. Petersburg
country: Russian Federation
facility: Cardiology Research Institute of the Ministry of Health of the Russian Federation
city: St. Petersburg
country: Russian Federation
facility: City Alexandrovsky Hospital, ICU Department
city: St. Petersburg
country: Russian Federation
facility: City Hospital #31
city: St. Petersburg
country: Russian Federation
facility: City Hospital 8
city: St. Petersburg
country: Russian Federation
facility: Military Medical Academy
city: St. Petersburg
country: Russian Federation
facility: St. Elisabeth City Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Hospital of Russian Academy of Sciences
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Dzanelidze State Scientific Research Institute for Emergency Medical Care
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Medical Postgraduate Academy
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State University
city: Almeria
country: Spain
facility: Hospital de Torrecardenas
city: Barcelona
country: Spain
facility: Hospital Clinic y Provincial
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Cordoba
country: Spain
facility: Hospital Reina Sofia, in Cordoba
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Severo Ochoa
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Goteborg
country: Sweden
facility: Medicinkliniken
city: Gothenburg
country: Sweden
facility: Avd. for intermedicin
city: Linkoping
country: Sweden
facility: Kardiologkliniken
city: Malmo
country: Sweden
facility: Kardiologkliniken
city: Molndal
country: Sweden
facility: Forskiningsenheten,
city: Stockholm
country: Sweden
facility: Enheten for internmedicin, Karolinska Institutet
city: Stockholm
country: Sweden
facility: Hjartkliniken, M84
city: Stockholm
country: Sweden
facility: Kardiologkliniken
city: Umea
country: Sweden
facility: Hjartcentrum,
city: Uppsala
country: Sweden
facility: Cardiologkliniken, Avd 50F
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Manchester
country: United Kingdom
facility: Northern Manchester General Hospital
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
Study officials:
References:
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