ID

39383

Beschrijving

Oral BG9928 in Patients With Heart Failure and Renal Insufficiency; ODM derived from: https://clinicaltrials.gov/show/NCT00745316

Link

https://clinicaltrials.gov/show/NCT00745316

Trefwoorden

Versies (1)
  1. 05-01-20 05-01-20 -
Houder van rechten

See clinicaltrials.gov

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5 januari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT00745316

Engels

Eligibility Heart Failure NCT00745316

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of heart failure requiring hospitalization >1 and ≤12 months prior to screening
Beschrijving

Heart failure | Hospitalization Required

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1708385
nyha class iii or iv at the time of screening
Beschrijving

New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
renal insufficiency as defined by egfr ≥20 and ≤70 ml/min/1.73 m2
Beschrijving

Renal Insufficiency | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of an allergic reaction to any xanthine-containing compound.
Beschrijving

Allergic Reaction Compound Containing Xanthine

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0043314
history of seizure
Beschrijving

Seizures

Datatype

boolean

Alias
UMLS CUI [1]
C0036572
history of stroke
Beschrijving

Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
serious systemic infection
Beschrijving

Sepsis Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205404
sustained systolic blood pressure >170 or <90 mmhg
Beschrijving

Systolic Pressure Sustained

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0443318
myocardial infarction within 30 days of day 1
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
hemodynamically destabilizing arrhythmia within 30 days of day 1
Beschrijving

Cardiac Arrhythmia

Datatype

boolean

Alias
UMLS CUI [1]
C0003811
uncorrected hemodynamically significant primary valvular disease
Beschrijving

Valvular disease uncorrected

Datatype

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C4072785
known obstructive or restrictive cardiomyopathy
Beschrijving

Hypertrophic obstructive cardiomyopathy | Restrictive cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0007196
cardiac surgery within 60 days prior to day 1
Beschrijving

Cardiac Surgery procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0018821
likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months
Beschrijving

Heart Transplantation Probably | Insertion of therapeutic device Probably | Cardiac Surgery procedure Probably

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0750492
UMLS CUI [2,1]
C0184961
UMLS CUI [2,2]
C0750492
UMLS CUI [3,1]
C0018821
UMLS CUI [3,2]
C0750492
evidence of malignancy within 6 months prior to day 1.
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
participation in any other investigational study of drugs or devices within 30 days prior to day 1.
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine
Beschrijving

Aminophylline | Theophylline | Pentoxifylline | Dyphylline | Adenosine

Datatype

boolean

Alias
UMLS CUI [1]
C0002575
UMLS CUI [2]
C0039771
UMLS CUI [3]
C0030899
UMLS CUI [4]
C0013360
UMLS CUI [5]
C0001443
presence of any clinically significant condition that might interfere with optimal safe participation in this study
Beschrijving

Medical condition Study Subject Participation Status At risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
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Similar models

Eligibility Heart Failure NCT00745316

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Heart failure | Hospitalization Required
Item
diagnosis of heart failure requiring hospitalization >1 and ≤12 months prior to screening
boolean
C0018801 (UMLS CUI [1])
C1708385 (UMLS CUI [2])
New York Heart Association Classification
Item
nyha class iii or iv at the time of screening
boolean
C1275491 (UMLS CUI [1])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
renal insufficiency as defined by egfr ≥20 and ≤70 ml/min/1.73 m2
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Compound Containing Xanthine
Item
history of an allergic reaction to any xanthine-containing compound.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0043314 (UMLS CUI [1,4])
Seizures
Item
history of seizure
boolean
C0036572 (UMLS CUI [1])
Cerebrovascular accident
Item
history of stroke
boolean
C0038454 (UMLS CUI [1])
Sepsis Serious
Item
serious systemic infection
boolean
C0243026 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Systolic Pressure Sustained
Item
sustained systolic blood pressure >170 or <90 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
Myocardial Infarction
Item
myocardial infarction within 30 days of day 1
boolean
C0027051 (UMLS CUI [1])
Cardiac Arrhythmia
Item
hemodynamically destabilizing arrhythmia within 30 days of day 1
boolean
C0003811 (UMLS CUI [1])
Valvular disease uncorrected
Item
uncorrected hemodynamically significant primary valvular disease
boolean
C3258293 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Hypertrophic obstructive cardiomyopathy | Restrictive cardiomyopathy
Item
known obstructive or restrictive cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
C0007196 (UMLS CUI [2])
Cardiac Surgery procedure
Item
cardiac surgery within 60 days prior to day 1
boolean
C0018821 (UMLS CUI [1])
Heart Transplantation Probably | Insertion of therapeutic device Probably | Cardiac Surgery procedure Probably
Item
likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months
boolean
C0018823 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C0184961 (UMLS CUI [2,1])
C0750492 (UMLS CUI [2,2])
C0018821 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
Malignant Neoplasms
Item
evidence of malignancy within 6 months prior to day 1.
boolean
C0006826 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in any other investigational study of drugs or devices within 30 days prior to day 1.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Aminophylline | Theophylline | Pentoxifylline | Dyphylline | Adenosine
Item
receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine
boolean
C0002575 (UMLS CUI [1])
C0039771 (UMLS CUI [2])
C0030899 (UMLS CUI [3])
C0013360 (UMLS CUI [4])
C0001443 (UMLS CUI [5])
Medical condition Study Subject Participation Status At risk
Item
presence of any clinically significant condition that might interfere with optimal safe participation in this study
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
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