ID

15404

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00270361

Palavras-chave

  1. 30/05/2016 30/05/2016 -
Transferido a

30 de maio de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Heart Failure, Congestive NCT00270361

Eligibility Heart Failure, Congestive NCT00270361

Inclusion Criteria
Descrição

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)
Descrição

congestive heart failure; therapeutic procedure

Tipo de dados

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
Descrição

congestive heart failure, decompensated, recent

Tipo de dados

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
Descrição

nyha

Tipo de dados

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)
Descrição

oral medication

Tipo de dados

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.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

systolic blood pressure

Tipo de dados

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
Descrição

organ transplantation

Tipo de dados

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
Descrição

informed consent, inotropes

Tipo de dados

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
Descrição

biventricular pacemaker

Tipo de dados

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.
Descrição

dialysis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011946

Similar models

Eligibility Heart Failure, Congestive NCT00270361

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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