Tezosentan in Acute Heart Failure
VERITAS 1
Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.
Sponsor study identifier
interventional
735
10 countries
35
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2005
Actual (reported)Study Completion
January 2005
Actual (reported)The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
January 2005
Actual (reported)January 2005
Actual (reported)August 31, 2007
Actual (reported)September 6, 2007
Actual (reported)Incidence of death or worsening heart failure
7 days following study drug initiation
effect on patient's dyspnea assessment, measured using a visual analog scale
Over first 24 hours
tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4ML/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4ML/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Alabama-Birmingham
Birmingham, Alabama, United States
Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section
Palo Alto, California, United States
Denver VAMC
Denver, Colorado, United States
The Heart Hospital at Alledgheny General, Division of Cardiology
Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center
Houston, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Danville Medical Center
Cotter G, Davison BA, Milo O, Bourge RC, Cleland JG, Jondeau G, Krum H, O'Connor CM, Metra M, Parker JD, Torre-Amione G, van Veldhuisen DJ, Kobrin I, Rainisio M, Senger S, Edwards C, McMurray JJ, Teerlink JR; VERITAS Investigators. Predictors and Associations With Outcomes of Length of Hospital Stay in Patients With Acute Heart Failure: Results From VERITAS. J Card Fail. 2016 Oct;22(10):815-22. doi: 10.1016/j.cardfail.2015.12.017. Epub 2015 Dec 22.
McMurray JJ, Teerlink JR, Cotter G, Bourge RC, Cleland JG, Jondeau G, Krum H, Metra M, O'Connor CM, Parker JD, Torre-Amione G, van Veldhuisen DJ, Lewsey J, Frey A, Rainisio M, Kobrin I; VERITAS Investigators. Effects of tezosentan on symptoms and clinical outcomes in patients with acute heart failure: the VERITAS randomized controlled trials. JAMA. 2007 Nov 7;298(17):2009-19. doi: 10.1001/jama.298.17.2009.
735 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2007
First Posted
September 6, 2007
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Danville, Virginia, United States
Medical Associates, Bellebue
Bellevue, Washington, United States
AKH University of Vienna, Abt. Medizinische Kardiologie
Vienna, Austria
Roskilde Amt Sygehus
Roskilde, Denmark
Hopital Ambroise Pare, Service de Cardiologie
Boulogne, France
Heart Failure clinic C.H. Dubos
Pontoise, France
Hopitaux Universitaires de Strasbourg, Hopital Hautepierre
Strasbourg, France
CHU Rangueil, Cardiologie A
Toulouse, France
Medizinische Klinik I, Universitatsklinikum Aachen
Aachen, Germany
Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie
Berlin, Germany
Georg-August-Universitat Gottingen, Zentrum fur Innere Med
Göttingen, Germany
Dept. of Cardiology, University of Athens, Alexandra Hospital
Athens, Greece
Barzilai Hospital
Ashkelon, Israel
Carmel Medical Center
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Hadassah Hospital
Jerusalem, Israel
Nazareth Hospital EMMS
Nazareth, Israel
Assaf-Harofeh Medical Center
Ẕerifin, Israel
Klinika Kardiologii i Chorob Wewnetrznych, Samodzielny Publiczny Szpital
Bydgoszcz, Poland
Klinika Chorob Serca, Akademia Medyczna w Gdansku
Gdansk, Poland
I Klinika Kardiolgii, Collegium Medicum UJ
Krakow, Poland
Institute of Cardiology College, College of Medicine of Jagellonian University
Krakow, Poland
Kategra I Klinika Kardiolgii AM
Wroclaw, Poland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
Cardio Centro Ticino, Servizio Cardiovasculare
Lugano, Switzerland
University Hospital Zurich
Zurich, Switzerland
Glasgow Royal Infirmary
Glasgow, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
Scunthorpe General Hospital
Scunthorpe, United Kingdom
Primary Completion
January 2005
Actual (reported)Study Completion
January 2005
Actual (reported)Last Updated
July 10, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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