ID

39383

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00745316

Stichworte

Versionen (1)
  1. 05.01.20 05.01.20 -
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See clinicaltrials.gov

Hochgeladen am

5. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00745316

Englisch

Eligibility Heart Failure NCT00745316

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Beschreibung

Age

Datentyp

boolean

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

Heart failure | Hospitalization Required

Datentyp

boolean

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

New York Heart Association Classification

Datentyp

boolean

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

Renal Insufficiency | Estimated Glomerular Filtration Rate

Datentyp

boolean

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

Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Allergic Reaction Compound Containing Xanthine

Datentyp

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
Beschreibung

Seizures

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
history of stroke
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
serious systemic infection
Beschreibung

Sepsis Serious

Datentyp

boolean

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

Systolic Pressure Sustained

Datentyp

boolean

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

Myocardial Infarction

Datentyp

boolean

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

Cardiac Arrhythmia

Datentyp

boolean

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

Valvular disease uncorrected

Datentyp

boolean

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

Hypertrophic obstructive cardiomyopathy | Restrictive cardiomyopathy

Datentyp

boolean

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

Cardiac Surgery procedure

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Malignant Neoplasms

Datentyp

boolean

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

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

Datentyp

boolean

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

Aminophylline | Theophylline | Pentoxifylline | Dyphylline | Adenosine

Datentyp

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
Beschreibung

Medical condition Study Subject Participation Status At risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
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Ähnliche Modelle

Eligibility Heart Failure NCT00745316

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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