ID

27793

Beschrijving

Study to Demonstrate the Non-inferiority of Olmesartan Medoxomil Versus Candesartan Cilexetil in Reducing Blood B-type (or Brain) Natriuretic Peptide Levels at Week 24; ODM derived from: https://clinicaltrials.gov/show/NCT00679484

Link

https://clinicaltrials.gov/show/NCT00679484

Trefwoorden

Versies (1)
  1. 29-11-17 29-11-17 -
Houder van rechten

See clinicaltrials.gov

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29 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Heart Failure NCT00679484

Engels

Eligibility Chronic Heart Failure NCT00679484

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, adult, out-patients aged between 18 and 85 years
Beschrijving

Adult | Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0029921
UMLS CUI [3]
C0001779
patients with documented hospital admission within the previous 3 months before randomization with discharge diagnosis of chf
Beschrijving

Hospital admission | Discharge diagnosis Congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0184666
UMLS CUI [2,1]
C1555319
UMLS CUI [2,2]
C0018802
patients with functional nyha class ii-iv with lvef < 40% assessed within the last 3 months
Beschrijving

New York Heart Association Classification | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0428772
patients with blood bnp levels > 400 pg/ml or nt-probnp levels > 1500 pg/ml
Beschrijving

Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
patients with chf due to ischemic heart disease, idiopathic dilated cardiomyopathy (idc), mitral or aortic insufficiency or hypertension
Beschrijving

Congestive heart failure Due to Myocardial Ischemia | Congestive heart failure Due to Idiopathic Dilated Cardiomyopathy | Congestive heart failure Due to Mitral Valve Insufficiency | Congestive heart failure Due to Aortic Valve Insufficiency | Congestive heart failure Due to Hypertensive disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0151744
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1449563
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0026266
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0003504
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0020538
patients with stable conventional treatment with diuretics, acei and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance
Beschrijving

Diuretics Stable | Angiotensin-Converting Enzyme Inhibitors Stable | Adrenergic beta-1 Receptor Antagonists Stable | Aldosterone Antagonists Stable | Exception Medical contraindication | Exception Intolerance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012798
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0304516
UMLS CUI [3,2]
C0205360
UMLS CUI [4,1]
C0002007
UMLS CUI [4,2]
C0205360
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1301624
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1744706
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. if a female becomes pregnant during the study, she has to be withdrawn immediately
Beschrijving

Pregnancy | Pregnancy, Planned | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332268
patients with current hospitalisation due to heart failure
Beschrijving

Hospitalization Due to Heart Failure

Datatype

boolean

Alias
UMLS CUI [1]
C3898876
patients with stroke or transient ischemic attack (tia) within the last 3 months
Beschrijving

Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months
Beschrijving

Acute Coronary Syndrome | Myocardial Infarction | Coronary Artery Bypass | Angioplasty

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0162577
planned cardiac surgery, revascularization or resynchronization within the study period
Beschrijving

Cardiac Surgery Planned | Cardiac Revascularization Planned | Cardiac Resynchronization Therapy Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0027056
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C1167956
UMLS CUI [3,2]
C1301732
patients with operable valvular disease or significant obstructive cardiomyopathy
Beschrijving

Valvular disease Operable | Obstructive Cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0205188
UMLS CUI [2]
C0007194
patients with bradycardia [heart rate (hr) < 50 bpm]
Beschrijving

Bradycardia | Heart rate

Datatype

boolean

Alias
UMLS CUI [1]
C0428977
UMLS CUI [2]
C0018810
patients with hypotension [systolic blood pressure (sbp) < 90 mmhg]
Beschrijving

Hypotension | Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
patients with obstructive pneumopathy
Beschrijving

Lung Diseases, Obstructive

Datatype

boolean

Alias
UMLS CUI [1]
C0600260
patients with clinical significant renal failure (creatininemia > 200 micromol/l)
Beschrijving

Kidney Failure | Creatinine measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201975
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Similar models

Eligibility Chronic Heart Failure NCT00679484

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Outpatients | Age
Item
male or female, adult, out-patients aged between 18 and 85 years
boolean
C0001675 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Hospital admission | Discharge diagnosis Congestive heart failure
Item
patients with documented hospital admission within the previous 3 months before randomization with discharge diagnosis of chf
boolean
C0184666 (UMLS CUI [1])
C1555319 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])
New York Heart Association Classification | Left ventricular ejection fraction
Item
patients with functional nyha class ii-iv with lvef < 40% assessed within the last 3 months
boolean
C1275491 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
patients with blood bnp levels > 400 pg/ml or nt-probnp levels > 1500 pg/ml
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Congestive heart failure Due to Myocardial Ischemia | Congestive heart failure Due to Idiopathic Dilated Cardiomyopathy | Congestive heart failure Due to Mitral Valve Insufficiency | Congestive heart failure Due to Aortic Valve Insufficiency | Congestive heart failure Due to Hypertensive disease
Item
patients with chf due to ischemic heart disease, idiopathic dilated cardiomyopathy (idc), mitral or aortic insufficiency or hypertension
boolean
C0018802 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0151744 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1449563 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0026266 (UMLS CUI [3,3])
C0018802 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0003504 (UMLS CUI [4,3])
C0018802 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0020538 (UMLS CUI [5,3])
Diuretics Stable | Angiotensin-Converting Enzyme Inhibitors Stable | Adrenergic beta-1 Receptor Antagonists Stable | Aldosterone Antagonists Stable | Exception Medical contraindication | Exception Intolerance
Item
patients with stable conventional treatment with diuretics, acei and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance
boolean
C0012798 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0304516 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0002007 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1301624 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1744706 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. if a female becomes pregnant during the study, she has to be withdrawn immediately
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
Hospitalization Due to Heart Failure
Item
patients with current hospitalisation due to heart failure
boolean
C3898876 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
patients with stroke or transient ischemic attack (tia) within the last 3 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Acute Coronary Syndrome | Myocardial Infarction | Coronary Artery Bypass | Angioplasty
Item
patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0162577 (UMLS CUI [4])
Cardiac Surgery Planned | Cardiac Revascularization Planned | Cardiac Resynchronization Therapy Planned
Item
planned cardiac surgery, revascularization or resynchronization within the study period
boolean
C0018821 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0027056 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1167956 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Valvular disease Operable | Obstructive Cardiomyopathy
Item
patients with operable valvular disease or significant obstructive cardiomyopathy
boolean
C3258293 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C0007194 (UMLS CUI [2])
Bradycardia | Heart rate
Item
patients with bradycardia [heart rate (hr) < 50 bpm]
boolean
C0428977 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
Hypotension | Systolic Pressure
Item
patients with hypotension [systolic blood pressure (sbp) < 90 mmhg]
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Lung Diseases, Obstructive
Item
patients with obstructive pneumopathy
boolean
C0600260 (UMLS CUI [1])
Kidney Failure | Creatinine measurement
Item
patients with clinical significant renal failure (creatininemia > 200 micromol/l)
boolean
C0035078 (UMLS CUI [1])
C0201975 (UMLS CUI [2])
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