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Acute Heart FailurePhase 3VERITAS 2NCT00524433

Tezosentan in the Treatment of Acute Heart Failure

A Phase 3 study testing tezosentan in people with Acute Heart Failure and Acute Decompensation of Chronic Heart Failure, run by Idorsia Pharmaceuticals Ltd. at 42 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tezosentan
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
713 participants
Where
42 sitesin 8 countries
Study dates
Apr 2003to Jan 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

42 sites in 8 countries.

42 sites in 8 countries

United States16 sites

  • University Hospital

    Augusta, Georgia

  • University of North Carolina

    Chapel Hill, North Carolina

  • Duke University Medical Center

    Durham, North Carolina

  • Elmhurst Hospital Center

    Elmhurst, New York

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina

  • Baylor College of Medicine - Texas Medical Center

    Houston, Texas

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas

  • Oracle Research

    Huntsville, Alabama

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida

  • USC Medical Center

    Los Angeles, California

  • University of Miami-Jackson Memorial Hospital

    Miami, Florida

  • Columbia Presbyterian Medical Center-Heart Failure Center

    New York, New York

  • New York University School of Medicine

    New York, New York

  • Medical Research Institute

    Slidell, Louisiana

  • Baystate Medical Center-Cardiology Section

    Springfield, Massachusetts

Other trials in United States

Czechia5 sites

  • Faculty Hospital St. Anna

    Brno

  • Krajska Nemocnice Liberec

    Liberec, Husova 10

  • Klinika Kardiologie IKEM

    Prague

  • University Hospital Vinohrady (FNKV)

    Prague

  • Masaryk Hospital

    Ústí nad Labem

Other trials in Czechia

Germany5 sites

  • Universitatsklinikum der Humboldt-Universitat Berlin, Campus Charite Mitte, Med. Klinik und Poliklinik, Kardiologie

    Berlin

  • Universitat Greifswald, Klinik fur Innere Medizin B

    Greifswald

  • Asklepios Klinik Langen, Abteilung fur Innere Medizin

    Langen

  • Universitatsklinikum Schleswig Holstein, Medizinische Klinik II, Kardiologie

    Lübeck

  • Klinik u. Poliklinik F. Inn. Med. II, Univ. Klinik Regensburg

    Regensburg

Other trials in Germany

Hungary4 sites

  • Jahn Ferenc, Delpesti Korhaz

    Budapest

  • Polyclinic of the Hospitaler Brothers of St. John of God

    Budapest

  • University of Debrecen

    Debrecen

  • 2nd Department of Medicine & Cardiology Centre

    Szeged

Other trials in Hungary

United Kingdom4 sites

  • University Department of Medicine, City Hospital

    Birmingham

  • Cardiology Department, Bridlington & District Hospital

    Bridlington

  • University of Glasgow West

    Glasgow

  • Dept. of Medicine & Therapeutics, University of Leicester

    Leicester

Other trials in United Kingdom

Australia3 sites

  • Concord Repatriation Hospital

    Concord NSW

  • Alfred Hospital, Monash University, Central and Eastern School

    Prahran, Victoria

  • Queen Elizabeth Hospital

    Woodville SA

Other trials in Australia

Norway3 sites

  • Sentralsykehuset i More og Romsdal, Dept. of Cardiology

    Ålesund

  • Aker University Hospital, Div. Cardiology

    Oslo

  • Central Hospital in Rogaland, Cardiology Division

    Stavanger

Other trials in Norway

Italy2 sites

  • Cattedra di Cardiologia, c/o Spedali Civili

    Brescia

  • Istituto Clinico Humanitas, U.O. Cardiologia Clin. E Insuff. Cardiaca

    Rozzano (MI)

Other trials in Italy

About this study

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.

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.

Being tested
tezosentan, placebo
Keywords
acute heart failure, acute decompensation of chronic heart failure, new onset of heart failure, tezosentan, Actelion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tezosentanDrug

    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)

  • placeboDrug

Study groups in NCT00524433
Study groupRoleWhat they receive
1Experimentaltezosentan
Receives: Drug: tezosentan
2Placebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of death or worsening heart failure

    Measured: within 7 days following study drug initiation

Secondary outcomes (1)

  1. Patient's dyspnea assessment, measured using a visual analog scale

    Measured: Over first 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2007 (estimated)
  2. Study startApr 2003
  3. Primary completionJan 2005
  4. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
713 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00524433
Sponsor's protocol ID
AC-051-307
Acronym
VERITAS 2
Status last verified
Jul 2018
First submitted
31 Aug 2007
Last updated
10 Jul 2018
Results posted
No

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.

    PubMed 26721775

  • 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.

    PubMed 17986694

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tezosentan in people with Acute Heart Failure and Acute Decompensation of Chronic Heart Failure, run by Idorsia Pharmaceuticals Ltd. at 42 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Czechia, Germany, Hungary, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of death or worsening heart failure (time frame: within 7 days following study drug initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00524433, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.

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