ID

33794

Beskrivning

Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01187836

Länk

https://clinicaltrials.gov/show/NCT01187836

Nyckelord

Versioner (1)
  1. 2018-12-27 2018-12-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 december 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01187836

Engelsk

Eligibility Heart Failure NCT01187836

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of congestive heart failure made at least 3 months prior to screening
Beskrivning

Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
nyha class iii or iv heart failure, ejection fraction </= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated.
Beskrivning

Heart failure New York Heart Association Classification | Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0232174
baseline mean pcwp >/= 20 mmhg
Beskrivning

Pulmonary Capillary Wedge Pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086879
UMLS CUI [1,2]
C0444504
systolic blood pressure at screening must be >/= 100 mmhg. heart rate at screening must be </= 90 bpm.
Beskrivning

Systolic Pressure | Heart rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0018810
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the investigator based on medical history, physical examination or laboratory tests.
Beskrivning

Disease Interferes with Safety Clinical Trial | Disease Interferes with Effectiveness Clinical Trial | Condition Interferes with Safety Clinical Trial | Condition Interferes with Effectiveness Clinical Trial | Medical History | Physical Examination | Laboratory Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0036043
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1280519
UMLS CUI [2,4]
C0008976
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0036043
UMLS CUI [3,4]
C0008976
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1280519
UMLS CUI [4,4]
C0008976
UMLS CUI [5]
C0262926
UMLS CUI [6]
C0031809
UMLS CUI [7]
C0022885
significant valve disease
Beskrivning

Valvular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C3258293
current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (acs) or coronary revascularization in the past 3 months.
Beskrivning

Sign or Symptom Myocardial Ischemia | Sign or Symptom Acute Coronary Syndrome | Sign or Symptom Coronary revascularisation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0151744
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0948089
UMLS CUI [3,1]
C3540840
UMLS CUI [3,2]
C0877341
sustained or uncontrolled ventricular arrhythmia. inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted.
Beskrivning

Ventricular arrhythmia Sustained | Ventricular arrhythmia Uncontrolled | Atrial Fibrillation | Heart rate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0443318
UMLS CUI [2,1]
C0085612
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0004238
UMLS CUI [4]
C0018810
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Similar models

Eligibility Heart Failure NCT01187836

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Congestive heart failure
Item
diagnosis of congestive heart failure made at least 3 months prior to screening
boolean
C0018802 (UMLS CUI [1])
Heart failure New York Heart Association Classification | Cardiac ejection fraction
Item
nyha class iii or iv heart failure, ejection fraction </= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2])
Pulmonary Capillary Wedge Pressure mean
Item
baseline mean pcwp >/= 20 mmhg
boolean
C0086879 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Systolic Pressure | Heart rate
Item
systolic blood pressure at screening must be >/= 100 mmhg. heart rate at screening must be </= 90 bpm.
boolean
C0871470 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Disease Interferes with Safety Clinical Trial | Disease Interferes with Effectiveness Clinical Trial | Condition Interferes with Safety Clinical Trial | Condition Interferes with Effectiveness Clinical Trial | Medical History | Physical Examination | Laboratory Procedures
Item
any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the investigator based on medical history, physical examination or laboratory tests.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1280519 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1280519 (UMLS CUI [4,3])
C0008976 (UMLS CUI [4,4])
C0262926 (UMLS CUI [5])
C0031809 (UMLS CUI [6])
C0022885 (UMLS CUI [7])
Valvular disease
Item
significant valve disease
boolean
C3258293 (UMLS CUI [1])
Sign or Symptom Myocardial Ischemia | Sign or Symptom Acute Coronary Syndrome | Sign or Symptom Coronary revascularisation
Item
current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (acs) or coronary revascularization in the past 3 months.
boolean
C3540840 (UMLS CUI [1,1])
C0151744 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0948089 (UMLS CUI [2,2])
C3540840 (UMLS CUI [3,1])
C0877341 (UMLS CUI [3,2])
Ventricular arrhythmia Sustained | Ventricular arrhythmia Uncontrolled | Atrial Fibrillation | Heart rate
Item
sustained or uncontrolled ventricular arrhythmia. inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted.
boolean
C0085612 (UMLS CUI [1,1])
C0443318 (UMLS CUI [1,2])
C0085612 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0004238 (UMLS CUI [3])
C0018810 (UMLS CUI [4])
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