Study Results
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Basic Information
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COMPLETED
PHASE3
735 participants
INTERVENTIONAL
2003-04-30
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
tezosentan
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)
2
tezosentan
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)
Interventions
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tezosentan
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)
Eligibility Criteria
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Inclusion Criteria
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
1. 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:
2. 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.
3. Cardiogenic shock within the last 48 hours or evidence of volume depletion.
4. Ongoing myocardial ischaemia, coronary revascularisation procedure (PCI or CABG) during current admission or planned revascularisation.
5. ST-segment elevation myocardial infarction or administration of thrombolytic therapy.
6. Baseline creatinine ≥ 2.5 mg/dl (221 mmol/l).
7. Baseline hemoglobin \< 10 g/dl or a hematocrit \< 30%.
8. Hemodialysis, ultrafiltration or peritoneal dialysis within the last 7 days.
9. Heart failure due to active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy or constrictive pericarditis. Heart failure caused by valvular disease.
10. Acute heart failure associated with uncontrolled hemodynamically relevant atrial fibrillation/flutter or ventricular rhythm disturbances.
11. Acute heart failure secondary to clinical evidence of digoxin toxicity or any other drug-related toxicity.
12. 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).
13. Mechanical circulatory or ventilatory support. Prior CPAP use is allowed, if discontinued at least 2 hours prior to study drug initiation.
14. Acute systemic infection/sepsis or other illness with a life expectancy less than 30 days.
15. Coronary artery bypass graft, or other cardiac surgery, or major non-cardiac surgery within the last 30 days.
16. Patients who received another investigational drug within 30 days prior to randomization.
17. Re-randomization in the current study.
18. Any factors that might interfere with the study conduct or interpretation of the results such as known drug or alcohol dependence.
19. Concomitant treatment with cyclosporin A or tacrolimus.
18 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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References
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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.
Other Identifiers
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AC-051-306
Identifier Type: -
Identifier Source: org_study_id
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