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Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.


Phase 3
18 Years
N/A
Not Enrolling
Both
Acute Heart Failure, Acute Decompensation of Chronic Heart Failure, New Onset of Heart Failure

Thank you

Trial Information

Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Incidence of death or worsening heart failure

Outcome Time Frame:

within 7 days following study drug initiation

Authority:

United States: Food and Drug Administration

Study ID:

AC-051-307

NCT ID:

NCT00524433

Start Date:

April 2003

Completion Date:

January 2005

Related Keywords:

  • Acute Heart Failure
  • Acute Decompensation of Chronic Heart Failure
  • New Onset of Heart Failure
  • acute heart failure
  • acute decompensation of chronic heart failure
  • new onset of heart failure
  • tezosentan
  • Actelion
  • Heart Failure

Name

Location

Elmhurst Hospital CenterElmhurst, New York  11373
University of Miami-Jackson Memorial HospitalMiami, Florida  33136
University of North CarolinaChapel Hill, North Carolina  27599
Duke University Medical CenterDurham, North Carolina  27710
New York University School of MedicineNew York, New York  10016
University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
University of Iowa Hospital and ClinicsIowa City, Iowa  52242
Jacksonville Center for Clinical ResearchJacksonville, Florida  32216
USC Medical CenterLos Angeles, California  90033
Oracle ResearchHuntsville, Alabama  
University HospitalAugusta, Georgia  
Medical Research InstituteSlidell, Louisiana  
Baystate Medical Center-Cardiology SectionSpringfield, Massachusetts  
Columbia Presbyterian Medical Center-Heart Failure CenterNew York, New York  
LeBauer Cardiovascular Research FoundationGreensboro, North Carolina  
Baylor College of Medicine - Texas Medical CenterHouston, Texas