ID

15404

Descrizione

FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR (Nesiritide) Administered to Patients With Worsening Congestive (Decompensated) Heart Failure Who Are Concurrently Receiving Their Usual Cardiac Medications and Are at High Risk for Hospitalization.; ODM derived from: https://clinicaltrials.gov/show/NCT00270361

collegamento

https://clinicaltrials.gov/show/NCT00270361

Keywords

  1. 30/05/16 30/05/16 -
Caricato su

30 maggio 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Heart Failure, Congestive NCT00270361

    Eligibility Heart Failure, Congestive NCT00270361

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects having had at least two hospital admissions (or equivalent treatment) for acutely decompensated chf within the last 12 months, with at least one of these admissions in the past 30 days, and having received treatment with intravenous vasoactive agents (such as intravenous inotropes, natrecor®, or nitroglycerin)
    Descrizione

    congestive heart failure; therapeutic procedure

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    UMLS CUI [2]
    C0087111
    able to be enrolled and initiate treatment with study drug within 5 to 30 days of last hospital discharge (or equivalent treatment) of acutely decompensated chf
    Descrizione

    congestive heart failure, decompensated, recent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802
    UMLS CUI [1,2]
    C0205434
    UMLS CUI [1,3]
    C0332185
    have a baseline nyha (new york heart association) functional classification iii or iv for at least 2 months prior to randomization
    Descrizione

    nyha

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1275491
    currently receiving optimal treatment with long term oral medications (e.g., diuretics, ace inhibitors, and beta blockers, unless beta blockers or ace inhibitors are documented to be contraindicated or not tolerated)
    Descrizione

    oral medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0175795
    willing to receive infusions of natrecor®, or possibly other medications, at least as frequently as once per week for 12 weeks.
    Descrizione

    informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subjects having systolic blood pressure consistently less than 90 mm hg
    Descrizione

    systolic blood pressure

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0871470
    having had organ transplantation (heart, liver, lung and kidney) in the past or anticipating organ transplantation during the study
    Descrizione

    organ transplantation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0029216
    not able or willing to discontinue intermittent or continuous infusions of inotropes if randomized to a natrecor® treatment group
    Descrizione

    informed consent, inotropes

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0304509
    having had a bi-ventricular pacemaker placed within the past 60 days or an automatic implantable cardiac defibrillator placed within the past 30 days
    Descrizione

    biventricular pacemaker

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1719274
    UMLS CUI [2]
    C0162589
    requiring chronic dialysis or have an expectation that dialysis will be required during the course of the study.
    Descrizione

    dialysis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0011946

    Similar models

    Eligibility Heart Failure, Congestive NCT00270361

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    congestive heart failure; therapeutic procedure
    Item
    subjects having had at least two hospital admissions (or equivalent treatment) for acutely decompensated chf within the last 12 months, with at least one of these admissions in the past 30 days, and having received treatment with intravenous vasoactive agents (such as intravenous inotropes, natrecor®, or nitroglycerin)
    boolean
    C0018802 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
    congestive heart failure, decompensated, recent
    Item
    able to be enrolled and initiate treatment with study drug within 5 to 30 days of last hospital discharge (or equivalent treatment) of acutely decompensated chf
    boolean
    C0018802 (UMLS CUI [1,1])
    C0205434 (UMLS CUI [1,2])
    C0332185 (UMLS CUI [1,3])
    nyha
    Item
    have a baseline nyha (new york heart association) functional classification iii or iv for at least 2 months prior to randomization
    boolean
    C1275491 (UMLS CUI [1])
    oral medication
    Item
    currently receiving optimal treatment with long term oral medications (e.g., diuretics, ace inhibitors, and beta blockers, unless beta blockers or ace inhibitors are documented to be contraindicated or not tolerated)
    boolean
    C0175795 (UMLS CUI [1])
    informed consent
    Item
    willing to receive infusions of natrecor®, or possibly other medications, at least as frequently as once per week for 12 weeks.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    systolic blood pressure
    Item
    subjects having systolic blood pressure consistently less than 90 mm hg
    boolean
    C0871470 (UMLS CUI [1])
    organ transplantation
    Item
    having had organ transplantation (heart, liver, lung and kidney) in the past or anticipating organ transplantation during the study
    boolean
    C0029216 (UMLS CUI [1])
    informed consent, inotropes
    Item
    not able or willing to discontinue intermittent or continuous infusions of inotropes if randomized to a natrecor® treatment group
    boolean
    C0021430 (UMLS CUI [1,1])
    C0304509 (UMLS CUI [1,2])
    biventricular pacemaker
    Item
    having had a bi-ventricular pacemaker placed within the past 60 days or an automatic implantable cardiac defibrillator placed within the past 30 days
    boolean
    C1719274 (UMLS CUI [1])
    C0162589 (UMLS CUI [2])
    dialysis
    Item
    requiring chronic dialysis or have an expectation that dialysis will be required during the course of the study.
    boolean
    C0011946 (UMLS CUI [1])

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