ID

80

Descrição

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

Link

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

Palavras-chave

Versões (3)
  1. 18/11/2011 18/11/2011 -
  2. 26/03/2014 26/03/2014 - Martin Dugas
  3. 13/04/2014 13/04/2014 - Julian Varghese
Transferido a

18 de novembro de 2011

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00894387 Heart Failure

Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Descrição

Inclusion criteria

primary diagnosis of worsening heart failure
Descrição

Diagnosis

Tipo de dados

boolean

age >= 18 years
Descrição

Age

Tipo de dados

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
Descrição

Symptoms

Tipo de dados

boolean

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

LVEF

Tipo de dados

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
Descrição

Hospitalization

Tipo de dados

boolean

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

BNP

Tipo de dados

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).
Descrição

History of heart failure

Tipo de dados

boolean

Exclusion criteria
Descrição

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.
Descrição

Prior medication

Tipo de dados

boolean

Concomitant use of ACEI and ARB at randomization.
Descrição

Concomitant use

Tipo de dados

boolean

Right heart failure due to pulmonary disease.
Descrição

Pulmonary disease

Tipo de dados

boolean

Diagnosis of postpartum cardiomyopathy.
Descrição

Cardiomyopathy

Tipo de dados

boolean

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

Myocardial infarction

Tipo de dados

boolean

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

Heart transplant

Tipo de dados

boolean

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

Coronary artery disease

Tipo de dados

boolean

Medical concepts
Descrição

Medical concepts

Diagnosis
Descrição

Diagnosis

Tipo de dados

string

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

Heart failure

Tipo de dados

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
Descrição

Age

Tipo de dados

string

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

NYHA

Tipo de dados

string

Alias
UMLS CUI
C1275491
SNOMED CT 2010_0731
420816009
Fatigability
Descrição

Fatigability

Tipo de dados

string

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

Dyspnea

Tipo de dados

string

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

Jugular venous distention

Tipo de dados

string

Alias
UMLS CUI
C1719935
SNOMED CT 2010_0731
422008005
Edema
Descrição

Oedema

Tipo de dados

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
Descrição

LVEF

Tipo de dados

string

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

Systolic Pressure

Tipo de dados

string

Alias
UMLS CUI
C0871470
SNOMED CT 2010_0731
271649006
Medication
Descrição

Pharmaceutical Preparations

Tipo de dados

string

Alias
UMLS CUI
C0013227
Vasodilating Agent
Descrição

Vasodilator

Tipo de dados

string

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

Cardiac inotropic agent

Tipo de dados

string

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

BNP

Tipo de dados

string

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

Randomization

Tipo de dados

string

Alias
UMLS CUI
C0034656
Angiotensin-Converting Enzyme Inhibitors
Descrição

ACE inhibitor

Tipo de dados

string

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

Angiotensin II Receptor Blocker (ARB)

Tipo de dados

string

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

Pulmonary disease

Tipo de dados

string

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

Right Heart Failure

Tipo de dados

string

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

Cardiomyopathy

Tipo de dados

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
Descrição

Acute myocardial infarction

Tipo de dados

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
Descrição

PTCA

Tipo de dados

string

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

Cardiac operation

Tipo de dados

string

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

Cardiac transplant

Tipo de dados

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
Descrição

Coronary artery bypass graft (CABG)

Tipo de dados

string

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

Coronary Heart Disease (CHD)

Tipo de dados

string

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

Angina Pectoris

Tipo de dados

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 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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