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

July 6, 2018 updated by: Idorsia Pharmaceuticals Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

713

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord NSW, Australia
        • Concord Repatriation Hospital
      • Woodville SA, Australia
        • Queen Elizabeth Hospital
    • Victoria
      • Prahran, Victoria, Australia
        • Alfred Hospital, Monash University, Central and Eastern School
  • Czechia
      • Brno, Czechia
        • Faculty Hospital St. Anna
      • Liberec, Czechia, Husova 10
        • Krajska Nemocnice Liberec
      • Prague, Czechia
        • Klinika Kardiologie IKEM
      • Prague, Czechia
        • University Hospital Vinohrady (FNKV)
      • Usti nad Labem, Czechia
        • Masaryk Hospital
  • Germany
      • Berlin, Germany
        • Universitatsklinikum der Humboldt-Universitat Berlin, Campus Charite Mitte, Med. Klinik und Poliklinik, Kardiologie
      • Greifswald, Germany
        • Universitat Greifswald, Klinik fur Innere Medizin B
      • Langen, Germany
        • Asklepios Klinik Langen, Abteilung fur Innere Medizin
      • Lubeck, Germany
        • Universitatsklinikum Schleswig Holstein, Medizinische Klinik II, Kardiologie
      • Regensburg, Germany
        • Klinik u. Poliklinik F. Inn. Med. II, Univ. Klinik Regensburg
  • Hungary
      • Budapest, Hungary
        • Jahn Ferenc, Delpesti Korhaz
      • Budapest, Hungary
        • Polyclinic of the Hospitaler Brothers of St. John of God
      • Debrecen, Hungary
        • University of Debrecen
      • Szeged, Hungary
        • 2nd Department of Medicine & Cardiology Centre
  • Italy
      • Brescia, Italy
        • Cattedra di Cardiologia, c/o Spedali Civili
      • Rozzano (MI), Italy
        • Istituto Clinico Humanitas, U.O. Cardiologia Clin. E Insuff. Cardiaca
  • Norway
      • Alesund, Norway
        • Sentralsykehuset i More og Romsdal, Dept. of Cardiology
      • Oslo, Norway
        • Aker University Hospital, Div. Cardiology
      • Stavanger, Norway
        • Central Hospital in Rogaland, Cardiology Division
  • United Kingdom
      • Birmingham, United Kingdom
        • University Department of Medicine, City Hospital
      • Bridlington, United Kingdom
        • Cardiology Department, Bridlington & District Hospital
      • Glasgow, United Kingdom
        • University of Glasgow West
      • Leicester, United Kingdom
        • Dept. of Medicine & Therapeutics, University of Leicester
  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • Oracle Research
    • California
      • Los Angeles, California, United States
        • USC Medical Center
    • Florida
      • Jacksonville, Florida, United States
        • Jacksonville Center for Clinical Research
      • Miami, Florida, United States
        • University of Miami-Jackson Memorial Hospital
    • Georgia
      • Augusta, Georgia, United States
        • University Hospital
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa Hospital and Clinics
    • Louisiana
      • Slidell, Louisiana, United States
        • Medical Research Institute
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Baystate Medical Center-Cardiology Section
    • New York
      • Elmhurst, New York, United States
        • Elmhurst Hospital Center
      • New York, New York, United States
        • New York University School of Medicine
      • New York, New York, United States
        • Columbia Presbyterian Medical Center-Heart Failure Center
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
      • Greensboro, North Carolina, United States
        • LeBauer Cardiovascular Research Foundation
    • Texas
      • Houston, Texas, United States
        • Baylor College of Medicine - Texas Medical Center
      • Houston, Texas, United States
        • University of Texas, MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: placebo
Experimental: 1
tezosentan
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of death or worsening heart failure
Time Frame: within 7 days following study drug initiation
within 7 days following study drug initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient's dyspnea assessment, measured using a visual analog scale
Time Frame: Over first 24 hours
Over first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idorsia Pharmaceuticals Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

August 31, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-051-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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