- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00525707
Tezosentan in Acute Heart Failure (VERITAS 1)
July 6, 2018 updated by: Idorsia Pharmaceuticals Ltd.
Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
735
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria
- AKH University of Vienna, Abt. Medizinische Kardiologie
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Roskilde, Denmark
- Roskilde Amt Sygehus
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Boulogne, France
- Hopital Ambroise Pare, Service de Cardiologie
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Pontoise, France
- Heart Failure clinic C.H. Dubos
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Strasbourg, France
- Hopitaux Universitaires de Strasbourg, Hopital Hautepierre
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Toulouse, France
- CHU Rangueil, Cardiologie A
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Aachen, Germany
- Medizinische Klinik I, Universitatsklinikum Aachen
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Berlin, Germany
- Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie
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Gottingen, Germany
- Georg-August-Universitat Gottingen, Zentrum fur Innere Med
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Athens, Greece
- Dept. of Cardiology, University of Athens, Alexandra Hospital
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Ashkelon, Israel
- Barzilai Hospital
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Haifa, Israel
- Carmel Medical Center
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Holon, Israel
- Wolfson Medical Center
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Jerusalem, Israel
- Hadassah Hospital
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Nazareth, Israel
- Nazareth Hospital EMMS
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Zerifin, Israel
- Assaf-Harofeh Medical Center
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Bydgoszcz, Poland
- Klinika Kardiologii i Chorob Wewnetrznych, Samodzielny Publiczny Szpital
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Gdansk, Poland
- Klinika Chorob Serca, Akademia Medyczna w Gdansku
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Krakow, Poland
- I Klinika Kardiolgii, Collegium Medicum UJ
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Krakow, Poland
- Institute of Cardiology College, College of Medicine of Jagellonian University
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Wroclaw, Poland
- Kategra I Klinika Kardiolgii AM
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Lausanne, Switzerland
- Centre Hospitalier Universitaire Vaudois (Chuv)
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Lugano, Switzerland
- Cardio Centro Ticino, Servizio Cardiovasculare
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Zurich, Switzerland
- University Hospital Zurich
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Glasgow, United Kingdom
- Glasgow Royal Infirmary
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Kingston Upon Hull, United Kingdom
- Hull Royal Infirmary
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Scunthorpe, United Kingdom
- Scunthorpe General Hospital
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Alabama
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Birmingham, Alabama, United States
- University of Alabama-Birmingham
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California
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Palo Alto, California, United States
- Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section
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Colorado
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Denver, Colorado, United States
- Denver VAMC
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- The Heart Hospital at Alledgheny General, Division of Cardiology
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Texas
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Houston, Texas, United States
- Veterans Affairs Medical Center
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Tyler, Texas, United States
- Tyler Cardiovascular Consultants
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Virginia
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Danville, Virginia, United States
- Danville Medical Center
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Washington
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Bellevue, Washington, United States
- Medical Associates, Bellebue
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients 18 years of age or older.
- Male or non-breast-feeding, non-pregnant female (only females who are post menopausal, surgically sterile or practicing a reliable method of contraception).
- Acute heart failure (ischemic or non-ischemic).
- Randomization within 24 hours of hospitalization (including emergency room stay) for acute heart failure.
- Dyspnea at rest as assessed by the patient and breathing rate ³ 24/min (measured during 60 seconds).
- 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).
- 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).
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: 2
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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)
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EXPERIMENTAL: 1
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)
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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)
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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: 7 days following study drug initiation
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7 days following study drug initiation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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effect on 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
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (ACTUAL)
January 1, 2005
Study Completion (ACTUAL)
January 1, 2005
Study Registration Dates
First Submitted
August 31, 2007
First Submitted That Met QC Criteria
September 5, 2007
First Posted (ESTIMATE)
September 6, 2007
Study Record Updates
Last Update Posted (ACTUAL)
July 10, 2018
Last Update Submitted That Met QC Criteria
July 6, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC-051-306
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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