Tezosentan in Acute Heart Failure (VERITAS 1)

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
735

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Austria
      • Vienna, Austria
        • AKH University of Vienna, Abt. Medizinische Kardiologie
  • Denmark
      • Roskilde, Denmark
        • Roskilde Amt Sygehus
  • France
      • Boulogne, France
        • Hopital Ambroise Pare, Service de Cardiologie
      • Pontoise, France
        • Heart Failure clinic C.H. Dubos
      • Strasbourg, France
        • Hopitaux Universitaires de Strasbourg, Hopital Hautepierre
      • Toulouse, France
        • CHU Rangueil, Cardiologie A
  • Germany
      • Aachen, Germany
        • Medizinische Klinik I, Universitatsklinikum Aachen
      • Berlin, Germany
        • Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie
      • Gottingen, Germany
        • Georg-August-Universitat Gottingen, Zentrum fur Innere Med
  • Greece
      • Athens, Greece
        • Dept. of Cardiology, University of Athens, Alexandra Hospital
  • Israel
      • Ashkelon, Israel
        • Barzilai Hospital
      • Haifa, Israel
        • Carmel Medical Center
      • Holon, Israel
        • Wolfson Medical Center
      • Jerusalem, Israel
        • Hadassah Hospital
      • Nazareth, Israel
        • Nazareth Hospital EMMS
      • Zerifin, Israel
        • Assaf-Harofeh Medical Center
  • Poland
      • Bydgoszcz, Poland
        • Klinika Kardiologii i Chorob Wewnetrznych, Samodzielny Publiczny Szpital
      • Gdansk, Poland
        • Klinika Chorob Serca, Akademia Medyczna w Gdansku
      • Krakow, Poland
        • I Klinika Kardiolgii, Collegium Medicum UJ
      • Krakow, Poland
        • Institute of Cardiology College, College of Medicine of Jagellonian University
      • Wroclaw, Poland
        • Kategra I Klinika Kardiolgii AM
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Lugano, Switzerland
        • Cardio Centro Ticino, Servizio Cardiovasculare
      • Zurich, Switzerland
        • University Hospital Zurich
  • United Kingdom
      • Glasgow, United Kingdom
        • Glasgow Royal Infirmary
      • Kingston Upon Hull, United Kingdom
        • Hull Royal Infirmary
      • Scunthorpe, United Kingdom
        • Scunthorpe General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama-Birmingham
    • California
      • Palo Alto, California, United States
        • Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section
    • Colorado
      • Denver, Colorado, United States
        • Denver VAMC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • The Heart Hospital at Alledgheny General, Division of Cardiology
    • Texas
      • Houston, Texas, United States
        • Veterans Affairs Medical Center
      • Tyler, Texas, United States
        • Tyler Cardiovascular Consultants
    • Virginia
      • Danville, Virginia, United States
        • Danville Medical Center
    • Washington
      • Bellevue, Washington, United States
        • Medical Associates, Bellebue

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: 2
Drug: tezosentan
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)
EXPERIMENTAL: 1
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
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of death or worsening heart failure
Time Frame: 7 days following study drug initiation
7 days following study drug initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
effect on 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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2003

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2005

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-051-306

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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