- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00524433
Tezosentan in the Treatment of Acute Heart Failure (VERITAS 2)
Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Concord NSW, Australia
- Concord Repatriation Hospital
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Woodville SA, Australia
- Queen Elizabeth Hospital
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Victoria
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Prahran, Victoria, Australia
- Alfred Hospital, Monash University, Central and Eastern School
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Brno, Czechia
- Faculty Hospital St. Anna
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Liberec, Czechia, Husova 10
- Krajská nemocnice Liberec
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Prague, Czechia
- Klinika Kardiologie IKEM
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Prague, Czechia
- University Hospital Vinohrady (FNKV)
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Usti nad Labem, Czechia
- Masaryk Hospital
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Berlin, Germany
- Universitatsklinikum der Humboldt-Universitat Berlin, Campus Charite Mitte, Med. Klinik und Poliklinik, Kardiologie
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Greifswald, Germany
- Universitat Greifswald, Klinik fur Innere Medizin B
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Langen, Germany
- Asklepios Klinik Langen, Abteilung fur Innere Medizin
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Lubeck, Germany
- Universitatsklinikum Schleswig Holstein, Medizinische Klinik II, Kardiologie
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Regensburg, Germany
- Klinik u. Poliklinik F. Inn. Med. II, Univ. Klinik Regensburg
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Budapest, Hungary
- Jahn Ferenc, Delpesti Korhaz
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Budapest, Hungary
- Polyclinic of the Hospitaler Brothers of St. John of God
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Debrecen, Hungary
- University of Debrecen
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Szeged, Hungary
- 2nd Department of Medicine & Cardiology Centre
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Brescia, Italy
- Cattedra di Cardiologia, c/o Spedali Civili
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Rozzano (MI), Italy
- Istituto Clinico Humanitas, U.O. Cardiologia Clin. E Insuff. Cardiaca
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Alesund, Norway
- Sentralsykehuset i More og Romsdal, Dept. of Cardiology
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Oslo, Norway
- Aker University Hospital, Div. Cardiology
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Stavanger, Norway
- Central Hospital in Rogaland, Cardiology Division
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Birmingham, United Kingdom
- University Department of Medicine, City Hospital
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Bridlington, United Kingdom
- Cardiology Department, Bridlington & District Hospital
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Glasgow, United Kingdom
- University of Glasgow West
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Leicester, United Kingdom
- Dept. of Medicine & Therapeutics, University of Leicester
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Alabama
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Huntsville, Alabama, United States
- Oracle Research
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California
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Los Angeles, California, United States
- USC Medical Center
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Florida
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Jacksonville, Florida, United States
- Jacksonville Center for Clinical Research
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Miami, Florida, United States
- University of Miami-Jackson Memorial Hospital
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Georgia
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Augusta, Georgia, United States
- University Hospital
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Iowa
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Iowa City, Iowa, United States
- University of Iowa Hospital and Clinics
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Louisiana
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Slidell, Louisiana, United States
- Medical Research Institute
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Massachusetts
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Springfield, Massachusetts, United States
- Baystate Medical Center-Cardiology Section
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New York
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Elmhurst, New York, United States
- Elmhurst Hospital Center
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New York, New York, United States
- New York University School of Medicine
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New York, New York, United States
- Columbia Presbyterian Medical Center-Heart Failure Center
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North Carolina
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Chapel Hill, North Carolina, United States
- University of North Carolina
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Durham, North Carolina, United States
- Duke University Medical Center
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Greensboro, North Carolina, United States
- LeBauer Cardiovascular Research Foundation
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Texas
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Houston, Texas, United States
- Baylor College of Medicine - Texas Medical Center
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Houston, Texas, United States
- University of Texas, MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1.Patients 18 years of age or older. 2.Male or non-breast-feeding, non-pregnant female (only females who are post menopausal, surgically sterile or practicing a reliable method of contraception).
3.Acute heart failure (ischemic or non-ischemic). 4.Randomization within 24 hours of hospitalization (including emergency room stay) for acute heart failure.
5.Dyspnea at rest as assessed by the patient and breathing rate ³ 24/min (measured during 60 seconds).
6.At least two out of the following four criteria: · elevated BNP or N terminal pro-BNP (more than three times the upper limit of normal for the site) in patients not treated with nesiritide,· clinical evidence of pulmonary congestion/edema (e.g., rales or crackles more than a third above bases),· evidence of pulmonary congestion on chest X-ray, · left ventricular systolic dysfunction (EF < 40% or wall motion index £ 1.2 within 12 months prior to randomization).
7.Patients in need of i.v. therapy for acute heart failure and who have received at least one dose of i.v. diuretic within 24 hours prior to study drug initiation (last bolus dose must have been more than 2 hours prior to study drug initiation).
8.Written informed consent.
Exclusion Criteria:
Criteria only for patients hemodynamically monitored:
Baseline cardiac index > 2.5 l/min/m2 and/or PCWP < 20 mmHg within 6 hours prior to study drug initiation.
Criteria for all patients:
- Patients not receiving i.v. vasodilators (e.g., nitrates, nitroprusside, nesiritide) at baseline: supine systolic blood pressure < 100 mmHg. Patients receiving i.v. vasodilators (e.g., nitrates, nitroprusside, nesiritide) at baseline: supine systolic blood pressure < 120 mmHg.
- Cardiogenic shock within the last 48 hours or evidence of volume depletion.
- Ongoing myocardial ischaemia, coronary revascularisation procedure (PCI or CABG) during current admission or planned revascularisation.
- ST-segment elevation myocardial infarction or administration of thrombolytic therapy.
- Baseline creatinine ≥ 2.5 mg/dl (221 mmol/l).
- Baseline hemoglobin < 10 g/dl or a hematocrit < 30%.
- Hemodialysis, ultrafiltration or peritoneal dialysis within the last 7 days.
- Heart failure due to active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy or constrictive pericarditis. Heart failure caused by valvular disease.
- Acute heart failure associated with uncontrolled hemodynamically relevant atrial fibrillation/flutter or ventricular rhythm disturbances.
- Acute heart failure secondary to clinical evidence of digoxin toxicity or any other drug-related toxicity.
- Significant chronic and/or acute lung disease that might interfere with the ability to interpret the dyspnea assessments or hemodynamic measurements (e.g., severe chronic obstructive pulmonary disease or acute pneumonia).
- Mechanical circulatory or ventilatory support. Prior CPAP use is allowed, if discontinued at least 2 hours prior to study drug initiation.
- Acute systemic infection/sepsis or other illness with a life expectancy less than 30 days.
- Coronary artery bypass graft, or other cardiac surgery, or major non-cardiac surgery within the last 30 days.
- Patients who received another investigational drug within 30 days prior to randomization.
- Re-randomization in the current study.
- Any factors that might interfere with the study conduct or interpretation of the results such as known drug or alcohol dependence.
- Concomitant treatment with cyclosporin A or tacrolimus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 2
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Experimental: 1
tezosentan
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tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4 mL/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of death or worsening heart failure
Time Frame: within 7 days following study drug initiation
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within 7 days following study drug initiation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Patient's dyspnea assessment, measured using a visual analog scale
Time Frame: Over first 24 hours
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Over first 24 hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC-051-307
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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