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Tezosentan in the Treatment of Acute Heart Failure (VERITAS 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524433
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : July 10, 2018
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Heart Failure Acute Decompensation of Chronic Heart Failure New Onset of Heart Failure Drug: tezosentan Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 713 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : April 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 1
Drug: tezosentan
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)

Placebo Comparator: 2 Drug: placebo

Primary Outcome Measures :
  1. Incidence of death or worsening heart failure [ Time Frame: within 7 days following study drug initiation ]

Secondary Outcome Measures :
  1. Patient's dyspnea assessment, measured using a visual analog scale [ Time Frame: Over first 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00524433

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Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Idorsia Pharmaceuticals Ltd. Identifier: NCT00524433    
Other Study ID Numbers: AC-051-307
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Keywords provided by Idorsia Pharmaceuticals Ltd.:
acute heart failure
acute decompensation of chronic heart failure
new onset of heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Vasodilator Agents