NCT00525707

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
735

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2003

Geographic Reach
10 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

August 31, 2007

Last Update Submit

July 6, 2018

Conditions

Acute Heart FailureAcute Decompensation of Chronic Heart FailureNew Onset of Heart Failure

Keywords

acute heart failureActeliontezosentanacute decompensation of chronic heart failureNew onset of heart failure

Outcome Measures

Primary Outcomes (1)

  • Incidence of death or worsening heart failure

    7 days following study drug initiation

Secondary Outcomes (1)

  • effect on patient's dyspnea assessment, measured using a visual analog scale

    Over first 24 hours

Study Arms (2)

1

EXPERIMENTAL

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)

Drug: tezosentan

2

PLACEBO COMPARATOR
Drug: tezosentan

Interventions

tezosentanDRUG

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)

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

University of Alabama-Birmingham

Birmingham, Alabama, United States

Location

Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section

Palo Alto, California, United States

Location

Denver VAMC

Denver, Colorado, United States

Location

The Heart Hospital at Alledgheny General, Division of Cardiology

Pittsburgh, Pennsylvania, United States

Location

Veterans Affairs Medical Center

Houston, Texas, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Location

Danville Medical Center

Danville, Virginia, United States

Location

Medical Associates, Bellebue

Bellevue, Washington, United States

Location

AKH University of Vienna, Abt. Medizinische Kardiologie

Vienna, Austria

Location

Roskilde Amt Sygehus

Roskilde, Denmark

Location

Hopital Ambroise Pare, Service de Cardiologie

Boulogne, France

Location

Heart Failure clinic C.H. Dubos

Pontoise, France

Location

Hopitaux Universitaires de Strasbourg, Hopital Hautepierre

Strasbourg, France

Location

CHU Rangueil, Cardiologie A

Toulouse, France

Location

Medizinische Klinik I, Universitatsklinikum Aachen

Aachen, Germany

Location

Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie

Berlin, Germany

Location

Georg-August-Universitat Gottingen, Zentrum fur Innere Med

Göttingen, Germany

Location

Dept. of Cardiology, University of Athens, Alexandra Hospital

Athens, Greece

Location

Barzilai Hospital

Ashkelon, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Hadassah Hospital

Jerusalem, Israel

Location

Nazareth Hospital EMMS

Nazareth, Israel

Location

Assaf-Harofeh Medical Center

Ẕerifin, Israel

Location

Klinika Kardiologii i Chorob Wewnetrznych, Samodzielny Publiczny Szpital

Bydgoszcz, Poland

Location

Klinika Chorob Serca, Akademia Medyczna w Gdansku

Gdansk, Poland

Location

I Klinika Kardiolgii, Collegium Medicum UJ

Krakow, Poland

Location

Institute of Cardiology College, College of Medicine of Jagellonian University

Krakow, Poland

Location

Kategra I Klinika Kardiolgii AM

Wroclaw, Poland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

Location

Cardio Centro Ticino, Servizio Cardiovasculare

Lugano, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

Glasgow Royal Infirmary

Glasgow, United Kingdom

Location

Hull Royal Infirmary

Hull, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 26721775DERIVED

  • 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.

    PMID: 17986694DERIVED

MeSH Terms

Interventions

tezosentan

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 6, 2007

Study Start

April 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

DK(1)CH(3)IL(6)AU(1)FR(4)DE(3)US(8)GR(1)GB(3)PL(5)