ID

80

Beschrijving

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00894387

Link

http://clinicaltrials.gov/ct2/show/record/NCT00894387

Trefwoorden

Versies (3)
  1. 18-11-11 18-11-11 -
  2. 26-03-14 26-03-14 - Martin Dugas
  3. 13-04-14 13-04-14 - Julian Varghese
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18 november 2011

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00894387 Heart Failure

Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschrijving

Inclusion criteria

primary diagnosis of worsening heart failure
Beschrijving

Diagnosis

Datatype

boolean

age >= 18 years
Beschrijving

Age

Datatype

boolean

acute heart failure symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization
Beschrijving

Symptoms

Datatype

boolean

LVEF less than 40% (measured within the last 6 months)
Beschrijving

LVEF

Datatype

boolean

Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP >= 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization
Beschrijving

Hospitalization

Datatype

boolean

Elevated BNP at Visit 1 or at randomization (BNP >= 400 pg/ml)
Beschrijving

BNP

Datatype

boolean

Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
Beschrijving

History of heart failure

Datatype

boolean

Exclusion criteria
Beschrijving

Exclusion criteria

Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
Beschrijving

Prior medication

Datatype

boolean

Concomitant use of ACEI and ARB at randomization.
Beschrijving

Concomitant use

Datatype

boolean

Right heart failure due to pulmonary disease.
Beschrijving

Pulmonary disease

Datatype

boolean

Diagnosis of postpartum cardiomyopathy.
Beschrijving

Cardiomyopathy

Datatype

boolean

Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
Beschrijving

Myocardial infarction

Datatype

boolean

Patients with a history of heart transplant or who are on a transplant list.
Beschrijving

Heart transplant

Datatype

boolean

Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
Beschrijving

Coronary artery disease

Datatype

boolean

Medical concepts
Beschrijving

Medical concepts

Diagnosis
Beschrijving

Diagnosis

Datatype

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Heart failure
Beschrijving

Heart failure

Datatype

string

Alias
UMLS CUI
C0018801
SNOMED CT 2010_0731
155374007
MedDRA 13.1
10019279
ICD-9-CM Version 2011
428
CTCAE Version 4.03
E10124
Age
Beschrijving

Age

Datatype

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
New York Heart Association Classification
Beschrijving

NYHA

Datatype

string

Alias
UMLS CUI
C1275491
SNOMED CT 2010_0731
420816009
Fatigability
Beschrijving

Fatigability

Datatype

string

Alias
UMLS CUI
C0231230
SNOMED CT 2010_0731
79915001
MedDRA 13.1
10016252
Dyspnea
Beschrijving

Dyspnea

Datatype

string

Alias
UMLS CUI
C0013404
SNOMED CT 2010_0731
139201002
CTCAE Version 4.03
E13368
Jugular venous distention
Beschrijving

Jugular venous distention

Datatype

string

Alias
UMLS CUI
C1719935
SNOMED CT 2010_0731
422008005
Edema
Beschrijving

Oedema

Datatype

string

Alias
UMLS CUI
C0013604
SNOMED CT 2010_0731
423666004
MedDRA 13.1
10030095
LOINC Version 232
MTHU019803
ICD-10-CM Version 2010
R60.9
ICD-9-CM Version 2011
782.3
Cardiac ejection fraction
Beschrijving

LVEF

Datatype

string

Alias
UMLS CUI
C0232174
SNOMED CT 2010_0731
70822001
Systolic Blood Pressure
Beschrijving

Systolic Pressure

Datatype

string

Alias
UMLS CUI
C0871470
SNOMED CT 2010_0731
271649006
Medication
Beschrijving

Pharmaceutical Preparations

Datatype

string

Alias
UMLS CUI
C0013227
Vasodilating Agent
Beschrijving

Vasodilator

Datatype

string

Alias
UMLS CUI
C0042402
SNOMED CT 2010_0731
58944007
Inotropic agent
Beschrijving

Cardiac inotropic agent

Datatype

string

Alias
UMLS CUI
C0304509
SNOMED CT 2010_0731
111139005
Brain Natriuretic Peptide Measurement
Beschrijving

BNP

Datatype

string

Alias
UMLS CUI
C1095989
SNOMED CT 2010_0731
390917008
MedDRA 13.1
10053406
Random Allocation
Beschrijving

Randomization

Datatype

string

Alias
UMLS CUI
C0034656
Angiotensin-Converting Enzyme Inhibitors
Beschrijving

ACE inhibitor

Datatype

string

Alias
UMLS CUI
C0003015
SNOMED CT 2010_0731
372733002
Angiotensin II receptor antagonist
Beschrijving

Angiotensin II Receptor Blocker (ARB)

Datatype

string

Alias
UMLS CUI
C0521942
SNOMED CT 2010_0731
372913009
Lung diseases
Beschrijving

Pulmonary disease

Datatype

string

Alias
UMLS CUI
C0024115
SNOMED CT 2010_0731
19829001
MedDRA 13.1
10025082
ICD-10-CM Version 2010
J98.4
Right Ventricular Failure
Beschrijving

Right Heart Failure

Datatype

string

Alias
UMLS CUI
C0235527
SNOMED CT 2010_0731
128404006
MedDRA 13.1
10039163
Cardiomyopathy
Beschrijving

Cardiomyopathy

Datatype

string

Alias
UMLS CUI
CL411823
SNOMED CT 2010_0731
85898001
MedDRA 13.1
10007636
ICD-10-CM Version 2010
I42.9
ICD-9-CM Version 2011
425
Acute myocardial infarction
Beschrijving

Acute myocardial infarction

Datatype

string

Alias
UMLS CUI
C0155626
SNOMED CT 2010_0731
57054005
MedDRA 13.1
10000891
ICD-10-CM Version 2010
I21
ICD-9-CM Version 2011
410
Percutaneous Transluminal Coronary Angioplasty
Beschrijving

PTCA

Datatype

string

Alias
UMLS CUI
C2936173
SNOMED CT 2010_0731
11101003
MedDRA 13.1
10050339
Cardiac Surgery procedures
Beschrijving

Cardiac operation

Datatype

string

Alias
UMLS CUI
C0018821
SNOMED CT 2010_0731
64915003
MedDRA 13.1
10061026
Heart Transplantation
Beschrijving

Cardiac transplant

Datatype

string

Alias
UMLS CUI
C0018823
SNOMED CT 2010_0731
32413006
MedDRA 13.1
10019314
ICD-9-CM Version 2011
37.51
Coronary Artery Bypass Surgery
Beschrijving

Coronary artery bypass graft (CABG)

Datatype

string

Alias
UMLS CUI
C0010055
SNOMED CT 2010_0731
232717009
MedDRA 13.1
10011077
ICD-9-CM Version 2011
36.10
Coronary artery disease
Beschrijving

Coronary Heart Disease (CHD)

Datatype

string

Alias
UMLS CUI
C0010068
SNOMED CT 2010_0731
53741008
MedDRA 13.1
10068617
Ischemic chest pain
Beschrijving

Angina Pectoris

Datatype

string

Alias
UMLS CUI
C0002962
SNOMED CT 2010_0731
194828000
MedDRA 13.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
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Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion criteria
Diagnosis
Item
primary diagnosis of worsening heart failure
boolean
Age
Item
age >= 18 years
boolean
Symptoms
Item
acute heart failure symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization
boolean
LVEF
Item
LVEF less than 40% (measured within the last 6 months)
boolean
Hospitalization
Item
Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP >= 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization
boolean
BNP
Item
Elevated BNP at Visit 1 or at randomization (BNP >= 400 pg/ml)
boolean
History of heart failure
Item
Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
boolean
Item Group
Exclusion criteria
Prior medication
Item
Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
boolean
Concomitant use
Item
Concomitant use of ACEI and ARB at randomization.
boolean
Pulmonary disease
Item
Right heart failure due to pulmonary disease.
boolean
Cardiomyopathy
Item
Diagnosis of postpartum cardiomyopathy.
boolean
Myocardial infarction
Item
Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
boolean
Heart transplant
Item
Patients with a history of heart transplant or who are on a transplant list.
boolean
Coronary artery disease
Item
Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
boolean
Item Group
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Heart failure
Item
Heart failure
string
C0018801 (UMLS CUI)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE Version 4.03)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
NYHA
Item
New York Heart Association Classification
string
C1275491 (UMLS CUI)
420816009 (SNOMED CT 2010_0731)
Fatigability
Item
Fatigability
string
C0231230 (UMLS CUI)
79915001 (SNOMED CT 2010_0731)
10016252 (MedDRA 13.1)
Dyspnea
Item
Dyspnea
string
C0013404 (UMLS CUI)
139201002 (SNOMED CT 2010_0731)
E13368 (CTCAE Version 4.03)
Jugular venous distention
Item
Jugular venous distention
string
C1719935 (UMLS CUI)
422008005 (SNOMED CT 2010_0731)
Oedema
Item
Edema
string
C0013604 (UMLS CUI)
423666004 (SNOMED CT 2010_0731)
10030095 (MedDRA 13.1)
MTHU019803 (LOINC Version 232)
R60.9 (ICD-10-CM Version 2010)
782.3 (ICD-9-CM Version 2011)
LVEF
Item
Cardiac ejection fraction
string
C0232174 (UMLS CUI)
70822001 (SNOMED CT 2010_0731)
Systolic Pressure
Item
Systolic Blood Pressure
string
C0871470 (UMLS CUI)
271649006 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Vasodilator
Item
Vasodilating Agent
string
C0042402 (UMLS CUI)
58944007 (SNOMED CT 2010_0731)
Cardiac inotropic agent
Item
Inotropic agent
string
C0304509 (UMLS CUI)
111139005 (SNOMED CT 2010_0731)
BNP
Item
Brain Natriuretic Peptide Measurement
string
C1095989 (UMLS CUI)
390917008 (SNOMED CT 2010_0731)
10053406 (MedDRA 13.1)
Randomization
Item
Random Allocation
string
C0034656 (UMLS CUI)
ACE inhibitor
Item
Angiotensin-Converting Enzyme Inhibitors
string
C0003015 (UMLS CUI)
372733002 (SNOMED CT 2010_0731)
Angiotensin II Receptor Blocker (ARB)
Item
Angiotensin II receptor antagonist
string
C0521942 (UMLS CUI)
372913009 (SNOMED CT 2010_0731)
Pulmonary disease
Item
Lung diseases
string
C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
Right Heart Failure
Item
Right Ventricular Failure
string
C0235527 (UMLS CUI)
128404006 (SNOMED CT 2010_0731)
10039163 (MedDRA 13.1)
Cardiomyopathy
Item
Cardiomyopathy
string
CL411823 (UMLS CUI)
85898001 (SNOMED CT 2010_0731)
10007636 (MedDRA 13.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
Acute myocardial infarction
Item
Acute myocardial infarction
string
C0155626 (UMLS CUI)
57054005 (SNOMED CT 2010_0731)
10000891 (MedDRA 13.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
PTCA
Item
Percutaneous Transluminal Coronary Angioplasty
string
C2936173 (UMLS CUI)
11101003 (SNOMED CT 2010_0731)
10050339 (MedDRA 13.1)
Cardiac operation
Item
Cardiac Surgery procedures
string
C0018821 (UMLS CUI)
64915003 (SNOMED CT 2010_0731)
10061026 (MedDRA 13.1)
Cardiac transplant
Item
Heart Transplantation
string
C0018823 (UMLS CUI)
32413006 (SNOMED CT 2010_0731)
10019314 (MedDRA 13.1)
37.51 (ICD-9-CM Version 2011)
Coronary artery bypass graft (CABG)
Item
Coronary Artery Bypass Surgery
string
C0010055 (UMLS CUI)
232717009 (SNOMED CT 2010_0731)
10011077 (MedDRA 13.1)
36.10 (ICD-9-CM Version 2011)
Coronary Heart Disease (CHD)
Item
Coronary artery disease
string
C0010068 (UMLS CUI)
53741008 (SNOMED CT 2010_0731)
10068617 (MedDRA 13.1)
Angina Pectoris
Item
Ischemic chest pain
string
C0002962 (UMLS CUI)
194828000 (SNOMED CT 2010_0731)
10002383 (MedDRA 13.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
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