ID

15221

Description

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

Link

https://clinicaltrials.gov/show/NCT02359227

Keywords

Versions (1)
  1. 5/23/16 5/23/16 -
Uploaded on

May 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02359227

English

Eligibility Heart Failure NCT02359227

1 forms  
Criteria
Description

Criteria

male or female, ≥ 18 years of age
Description

Age

Data type

boolean

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

Body mass index

Data type

boolean

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

New York Heart Association Classification

Data type

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)
Description

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

Data type

boolean

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

Systolic Pressure

Data type

boolean

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

Heart failure oral medication | Therapeutic procedure Stable status

Data type

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:
Description

Exclusion Criteria Important

Data type

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
Description

Hypersensitivity Natriuretic Peptides | Hypersensitivity Natriuretic Peptides Component | Hypersensitivity Nesiritide

Data type

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)
Description

ADHF

Data type

boolean

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

Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
symptomatic postural hypotension
Description

Orthostatic Hypotension Symptomatic

Data type

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
Description

Sodium measurement volume | Medical condition predisposing Adverse event

Data type

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
Description

Aortic Valve Stenosis | Mitral Valve Stenosis

Data type

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)
Description

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

Data type

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
Description

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

Data type

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)
Description

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

Data type

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
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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