ID

15221

Beskrivning

Safety Study of Cenderitide in Stable Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02359227

Länk

https://clinicaltrials.gov/show/NCT02359227

Nyckelord

Versioner (1)
  1. 2016-05-23 2016-05-23 -
Uppladdad den

23 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02359227

Engelsk

Eligibility Heart Failure NCT02359227

1 Formulär  
Criteria
Beskrivning

Criteria

male or female, ≥ 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) of 18-40 kg/m2, inclusive
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
current or historical new york heart association (nyha) functional class ≥ ii
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
at least one of the following: documented systolic heart failure with an ejection fraction (ef) ≤ 40% and/or a historical measurement of plasma bnp ≥ 150 pg/ml (or nt-probnp ≥ 600 pg/ml)
Beskrivning

Heart Failure, Systolic | Ejection fraction | Brain natriuretic peptide measurement | Amino-terminal pro-brain natriuretic peptide

Datatyp

boolean

Alias
UMLS CUI [1]
C1135191
UMLS CUI [2]
C0489482
UMLS CUI [3]
C1095989
UMLS CUI [4]
C0754710
systolic blood pressure 100-160 mmhg
Beskrivning

Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to screening
Beskrivning

Heart failure oral medication | Therapeutic procedure Stable status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205360
key exclusion criteria:
Beskrivning

Exclusion Criteria Important

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3898777
known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
Beskrivning

Hypersensitivity Natriuretic Peptides | Hypersensitivity Natriuretic Peptides Component | Hypersensitivity Nesiritide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1144709
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1144709
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0054015
current clinical diagnosis of acute decompensated heart failure (adhf)
Beskrivning

ADHF

Datatyp

boolean

Alias
UMLS CUI [1]
C1609524
clinical diagnosis of acute coronary syndrome (acs) within 30 days prior to screening.
Beskrivning

Acute Coronary Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
symptomatic postural hypotension
Beskrivning

Orthostatic Hypotension Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020651
UMLS CUI [1,2]
C0231220
evidence of uncorrected volume or sodium ≤ 130 mmol/l or other condition that would predispose the patient to adverse events
Beskrivning

Sodium measurement volume | Medical condition predisposing Adverse event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C1690016
UMLS CUI [2,1]
C1699700
UMLS CUI [2,2]
C0231203
UMLS CUI [2,3]
C0877248
clinically significant aortic or mitral valve stenosis
Beskrivning

Aortic Valve Stenosis | Mitral Valve Stenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003507
UMLS CUI [2]
C0026269
acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
Beskrivning

Acute myocarditis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Mitral diastolic filling period

Datatyp

boolean

Alias
UMLS CUI [1]
C0155686
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
UMLS CUI [4]
C1299325
severe renal failure defined as creatinine clearance < 45 ml/min as estimated by either the cockcroft-gault or the mdrd equations
Beskrivning

Kidney Failure Severe | Creatinine clearance measurement | Cockcroft-Gault formula | MDRD

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0373595
UMLS CUI [3]
C2924627
UMLS CUI [4]
C3839656
significant pulmonary disease (e.g., history of oral daily steroid dependency, history of carbon dioxide (co2) retention or need for intubation for acute exacerbation, or currently receiving iv steroids)
Beskrivning

Lung diseases | STEROID DEPENDENCY Oral Daily | CO2 RETENTION CHRONIC | exacerbation acute Intubation | Intravenous steroid injection

Datatyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2,1]
C0749012
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0332173
UMLS CUI [3]
C0742501
UMLS CUI [4,1]
C0743630
UMLS CUI [4,2]
C0021925
UMLS CUI [5]
C0563322
known hepatic impairment as indicated by any of the following: a) total bilirubin > 3 mg/dl; b) albumin < 2.8 mg/dl, with other signs or symptoms of hepatic dysfunction; c) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction
Beskrivning

Hepatic impairment Indicated | Bilirubin, total measurement | Albumin measurement | Ammonia increased | Liver Dysfunction Sign or Symptom

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C1444656
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201838
UMLS CUI [4]
C0541772
UMLS CUI [5,1]
C0086565
UMLS CUI [5,2]
C3540840
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Similar models

Eligibility Heart Failure NCT02359227

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
male or female, ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 18-40 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
New York Heart Association Classification
Item
current or historical new york heart association (nyha) functional class ≥ ii
boolean
C1275491 (UMLS CUI [1])
Heart Failure, Systolic | Ejection fraction | Brain natriuretic peptide measurement | Amino-terminal pro-brain natriuretic peptide
Item
at least one of the following: documented systolic heart failure with an ejection fraction (ef) ≤ 40% and/or a historical measurement of plasma bnp ≥ 150 pg/ml (or nt-probnp ≥ 600 pg/ml)
boolean
C1135191 (UMLS CUI [1])
C0489482 (UMLS CUI [2])
C1095989 (UMLS CUI [3])
C0754710 (UMLS CUI [4])
Systolic Pressure
Item
systolic blood pressure 100-160 mmhg
boolean
C0871470 (UMLS CUI [1])
Heart failure oral medication | Therapeutic procedure Stable status
Item
stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to screening
boolean
C0018801 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Exclusion Criteria Important
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
Hypersensitivity Natriuretic Peptides | Hypersensitivity Natriuretic Peptides Component | Hypersensitivity Nesiritide
Item
known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
boolean
C0020517 (UMLS CUI [1,1])
C1144709 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1144709 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0054015 (UMLS CUI [3,2])
ADHF
Item
current clinical diagnosis of acute decompensated heart failure (adhf)
boolean
C1609524 (UMLS CUI [1])
Acute Coronary Syndrome
Item
clinical diagnosis of acute coronary syndrome (acs) within 30 days prior to screening.
boolean
C0948089 (UMLS CUI [1])
Orthostatic Hypotension Symptomatic
Item
symptomatic postural hypotension
boolean
C0020651 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Sodium measurement volume | Medical condition predisposing Adverse event
Item
evidence of uncorrected volume or sodium ≤ 130 mmol/l or other condition that would predispose the patient to adverse events
boolean
C0337443 (UMLS CUI [1,1])
C1690016 (UMLS CUI [1,2])
C1699700 (UMLS CUI [2,1])
C0231203 (UMLS CUI [2,2])
C0877248 (UMLS CUI [2,3])
Aortic Valve Stenosis | Mitral Valve Stenosis
Item
clinically significant aortic or mitral valve stenosis
boolean
C0003507 (UMLS CUI [1])
C0026269 (UMLS CUI [2])
Acute myocarditis | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Mitral diastolic filling period
Item
acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
boolean
C0155686 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
C1299325 (UMLS CUI [4])
Kidney Failure Severe | Creatinine clearance measurement | Cockcroft-Gault formula | MDRD
Item
severe renal failure defined as creatinine clearance < 45 ml/min as estimated by either the cockcroft-gault or the mdrd equations
boolean
C0035078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
C2924627 (UMLS CUI [3])
C3839656 (UMLS CUI [4])
Lung diseases | STEROID DEPENDENCY Oral Daily | CO2 RETENTION CHRONIC | exacerbation acute Intubation | Intravenous steroid injection
Item
significant pulmonary disease (e.g., history of oral daily steroid dependency, history of carbon dioxide (co2) retention or need for intubation for acute exacerbation, or currently receiving iv steroids)
boolean
C0024115 (UMLS CUI [1])
C0749012 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0742501 (UMLS CUI [3])
C0743630 (UMLS CUI [4,1])
C0021925 (UMLS CUI [4,2])
C0563322 (UMLS CUI [5])
Hepatic impairment Indicated | Bilirubin, total measurement | Albumin measurement | Ammonia increased | Liver Dysfunction Sign or Symptom
Item
known hepatic impairment as indicated by any of the following: a) total bilirubin > 3 mg/dl; b) albumin < 2.8 mg/dl, with other signs or symptoms of hepatic dysfunction; c) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction
boolean
C0948807 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
C0201913 (UMLS CUI [2])
C0201838 (UMLS CUI [3])
C0541772 (UMLS CUI [4])
C0086565 (UMLS CUI [5,1])
C3540840 (UMLS CUI [5,2])
Tillbaka till toppen 

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