ID

27793

Description

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

Keywords

Versions (1)
  1. 11/29/17 11/29/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 29, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Chronic Heart Failure NCT00679484

English

Eligibility Chronic Heart Failure NCT00679484

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adult | Outpatients | Age

Data type

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
Description

Hospital admission | Discharge diagnosis Congestive heart failure

Data type

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
Description

New York Heart Association Classification | Left ventricular ejection fraction

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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
Description

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

Data type

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
Description

Hospitalization Due to Heart Failure

Data type

boolean

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

Cerebrovascular accident | Transient Ischemic Attack

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Valvular disease Operable | Obstructive Cardiomyopathy

Data type

boolean

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

Bradycardia | Heart rate

Data type

boolean

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

Hypotension | Systolic Pressure

Data type

boolean

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

Lung Diseases, Obstructive

Data type

boolean

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

Kidney Failure | Creatinine measurement

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201975
Back to the top of the page

Similar models

Eligibility Chronic Heart Failure NCT00679484

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial