ID

39533

Beskrivning

This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01035255

Länk

https://clinicaltrials.gov/show/NCT01035255

Nyckelord

Versioner (1)
  1. 2020-01-24 2020-01-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 januari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure With Reduced Ejection Fraction NCT01035255

Engelsk

Eligibility Heart Failure With Reduced Ejection Fraction NCT01035255

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must give written informed consent before any assessment is performed.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
outpatients ≥ 18 years of age, male or female.
Beskrivning

Outpatients | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with a diagnosis of chf nyha class ii-iv and reduced ejection fraction (ef =< 35%) and elevated bnp.
Beskrivning

Chronic heart failure New York Heart Association Classification | Reduced ejection fraction | Cardiac ejection fraction | Brain natriuretic peptide increased

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C4022792
UMLS CUI [3]
C0232174
UMLS CUI [4]
C1095988
patients must be on an acei or an arb at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
Beskrivning

Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable | Enalapril Dose | Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0521942
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0014025
UMLS CUI [3,2]
C0178602
UMLS CUI [4]
C0205163
patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
Beskrivning

Adrenergic beta-Antagonist Dose Stable | Exception Medical contraindication | Exception Intolerance to substance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001645
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1301624
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1744706
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
history of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, aceis, arbs, or nep inhibitors as well as known or suspected contraindications to the study drugs.
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Angiotensin-converting-enzyme inhibitor allergy | Allergy to angiotensin II receptor antagonist | Hypersensitivity NEP inhibitors | Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2348205
UMLS CUI [3]
C0571939
UMLS CUI [4]
C2585204
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0025250
UMLS CUI [5,3]
C0243077
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0013230
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0750491
UMLS CUI [7,3]
C0013230
previous history of intolerance to recommended target doses of aceis or arbs
Beskrivning

Intolerance to Angiotensin-Converting Enzyme Inhibitors Dose | Intolerance to Angiotensin II receptor antagonist Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0003015
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0521942
UMLS CUI [2,3]
C0178602
known history of angioedema.
Beskrivning

Angioedema

Datatyp

boolean

Alias
UMLS CUI [1]
C0002994
requirement of treatment with both aceis and arbs.
Beskrivning

Angiotensin-Converting Enzyme Inhibitors Therapy Required | Angiotensin II receptor antagonist Therapy Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1514873
UMLS CUI [2,1]
C0521942
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1514873
current acute decompensated hf (exacerbation of chronic hf manifested by signs and symptoms that may require intravenous therapy).
Beskrivning

Decompensated cardiac failure | Exacerbation Chronic heart failure | Signs and Symptoms Requirement Intravenous therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0581377
UMLS CUI [2,1]
C4086268
UMLS CUI [2,2]
C0264716
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0455142
symptomatic hypotension and/or a sbp < 100 mmhg.
Beskrivning

Hypotension symptomatic | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0863113
UMLS CUI [2]
C0871470
estimated gfr < 30 ml/min/1.73m2 as measured by the simplified mdrd formula
Beskrivning

GFR estimation by MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C2170215
serum potassium > 5.2 mmol/l.
Beskrivning

Serum potassium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0302353
other protocol-defined inclusion/exclusion criteria may apply.
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Heart Failure With Reduced Ejection Fraction NCT01035255

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
patients must give written informed consent before any assessment is performed.
boolean
C0021430 (UMLS CUI [1])
Outpatients | Age
Item
outpatients ≥ 18 years of age, male or female.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic heart failure New York Heart Association Classification | Reduced ejection fraction | Cardiac ejection fraction | Brain natriuretic peptide increased
Item
patients with a diagnosis of chf nyha class ii-iv and reduced ejection fraction (ef =< 35%) and elevated bnp.
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C4022792 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
C1095988 (UMLS CUI [4])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable | Enalapril Dose | Equivalent
Item
patients must be on an acei or an arb at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0014025 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205163 (UMLS CUI [4])
Adrenergic beta-Antagonist Dose Stable | Exception Medical contraindication | Exception Intolerance to substance
Item
patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
boolean
C0001645 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1744706 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Angiotensin-converting-enzyme inhibitor allergy | Allergy to angiotensin II receptor antagonist | Hypersensitivity NEP inhibitors | Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs
Item
history of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, aceis, arbs, or nep inhibitors as well as known or suspected contraindications to the study drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0571939 (UMLS CUI [3])
C2585204 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0025250 (UMLS CUI [5,2])
C0243077 (UMLS CUI [5,3])
C1301624 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0750491 (UMLS CUI [7,2])
C0013230 (UMLS CUI [7,3])
Intolerance to Angiotensin-Converting Enzyme Inhibitors Dose | Intolerance to Angiotensin II receptor antagonist Dose
Item
previous history of intolerance to recommended target doses of aceis or arbs
boolean
C1744706 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Angioedema
Item
known history of angioedema.
boolean
C0002994 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors Therapy Required | Angiotensin II receptor antagonist Therapy Required
Item
requirement of treatment with both aceis and arbs.
boolean
C0003015 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Decompensated cardiac failure | Exacerbation Chronic heart failure | Signs and Symptoms Requirement Intravenous therapy
Item
current acute decompensated hf (exacerbation of chronic hf manifested by signs and symptoms that may require intravenous therapy).
boolean
C0581377 (UMLS CUI [1])
C4086268 (UMLS CUI [2,1])
C0264716 (UMLS CUI [2,2])
C0037088 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0455142 (UMLS CUI [3,3])
Hypotension symptomatic | Systolic Pressure
Item
symptomatic hypotension and/or a sbp < 100 mmhg.
boolean
C0863113 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
GFR estimation by MDRD
Item
estimated gfr < 30 ml/min/1.73m2 as measured by the simplified mdrd formula
boolean
C2170215 (UMLS CUI [1])
Serum potassium measurement
Item
serum potassium > 5.2 mmol/l.
boolean
C0302353 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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