ID

28390

Beschrijving

Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction; ODM derived from: https://clinicaltrials.gov/show/NCT01091467

Link

https://clinicaltrials.gov/show/NCT01091467

Trefwoorden

Versies (1)
  1. 10-01-18 10-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT01091467

Engels

Eligibility Congestive Heart Failure NCT01091467

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient presenting to the hospital with congestive heart failure, defined as:
Beschrijving

Congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
1. clinical signs of heart failure
Beschrijving

Sign or Symptom Heart failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0018801
major criteria
Beschrijving

Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1542147
paroxysmal nocturnal dyspnea
Beschrijving

Paroxysmal nocturnal dyspnea

Datatype

boolean

Alias
UMLS CUI [1]
C1956415
orthopnea
Beschrijving

Orthopnea

Datatype

boolean

Alias
UMLS CUI [1]
C0085619
jugular venous distension
Beschrijving

Jugular venous distension

Datatype

boolean

Alias
UMLS CUI [1]
C0425687
pulmonary crackling rales
Beschrijving

Rales

Datatype

boolean

Alias
UMLS CUI [1]
C0034642
3rd heart sound
Beschrijving

Third heart sound

Datatype

boolean

Alias
UMLS CUI [1]
C0232237
cardiothoracic ratio > 0.5 on x-ray
Beschrijving

Cardiothoracic ratio X-ray

Datatype

boolean

Alias
UMLS CUI [1,1]
C2363738
UMLS CUI [1,2]
C0034571
pulmonary oedema on x-ray
Beschrijving

Pulmonary Edema X-ray

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034063
UMLS CUI [1,2]
C0034571
minor criteria
Beschrijving

Criteria Secondary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0175668
peripheral oedema
Beschrijving

Peripheral edema

Datatype

boolean

Alias
UMLS CUI [1]
C0085649
nocturnal cough
Beschrijving

Nocturnal cough

Datatype

boolean

Alias
UMLS CUI [1]
C0231912
dyspnoea at exercise
Beschrijving

Dyspnea on exertion

Datatype

boolean

Alias
UMLS CUI [1]
C0231807
hepatomegaly
Beschrijving

Hepatomegaly

Datatype

boolean

Alias
UMLS CUI [1]
C0019209
pleural effusion
Beschrijving

Pleural effusion

Datatype

boolean

Alias
UMLS CUI [1]
C0032227
tachycardia (defined as ≥ 100 beats per minute)
Beschrijving

Tachycardia beats per minute

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039231
UMLS CUI [1,2]
C0439385
heart failure if: presence of 2 major criteria or 1 major + 2 minor criteria
Beschrijving

Heart failure | Criteria Main Quantity | Criteria Secondary Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C1265611
2. lvef ≥ 45% by echocardiography within 72h
Beschrijving

Echocardiography: left ventricular ejection fraction Timespan

Datatype

boolean

Alias
UMLS CUI [1,1]
C2097013
UMLS CUI [1,2]
C0872291
3. bnp > 100 ng/l or nt-probnp > 300 ng/l
Beschrijving

BNP | NT-proBNP

Datatype

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C0754710
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease
Beschrijving

Primary hypertrophic cardiomyopathy Associated with Heart Disease Infiltrating | Restrictive cardiomyopathy Associated with Heart Disease Infiltrating | Systemic disease Associated with Heart Disease Infiltrating

Datatype

boolean

Alias
UMLS CUI [1,1]
C3665332
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0018799
UMLS CUI [1,4]
C0332448
UMLS CUI [2,1]
C0007196
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0018799
UMLS CUI [2,4]
C0332448
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0018799
UMLS CUI [3,4]
C0332448
known cause of right heart failure not related to left ventricular dysfunction
Beschrijving

Right Heart Failure Cause Known | Independent of Left Ventricular Dysfunction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0235527
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205309
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0242698
pericardial constriction
Beschrijving

Pericardial constriction

Datatype

boolean

Alias
UMLS CUI [1]
C0240709
clinically significant pulmonary disease, as evidenced by requirement of home oxygen.
Beschrijving

Lung disease | Home oxygen supply Required

Datatype

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2,1]
C0421203
UMLS CUI [2,2]
C1514873
end-stage renal disease requiring dialysis
Beschrijving

Kidney Failure, Chronic | Dialysis Required

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C1514873
bi-ventricular pacemaker (crt)
Beschrijving

Biventricular Pacemaker | Cardiac Resynchronization Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1719274
UMLS CUI [2]
C1167956
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Similar models

Eligibility Congestive Heart Failure NCT01091467

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Congestive heart failure
Item
patient presenting to the hospital with congestive heart failure, defined as:
boolean
C0018802 (UMLS CUI [1])
Sign or Symptom Heart failure
Item
1. clinical signs of heart failure
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Criteria Main
Item
major criteria
boolean
C0243161 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Paroxysmal nocturnal dyspnea
Item
paroxysmal nocturnal dyspnea
boolean
C1956415 (UMLS CUI [1])
Orthopnea
Item
orthopnea
boolean
C0085619 (UMLS CUI [1])
Jugular venous distension
Item
jugular venous distension
boolean
C0425687 (UMLS CUI [1])
Rales
Item
pulmonary crackling rales
boolean
C0034642 (UMLS CUI [1])
Third heart sound
Item
3rd heart sound
boolean
C0232237 (UMLS CUI [1])
Cardiothoracic ratio X-ray
Item
cardiothoracic ratio > 0.5 on x-ray
boolean
C2363738 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Pulmonary Edema X-ray
Item
pulmonary oedema on x-ray
boolean
C0034063 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Criteria Secondary
Item
minor criteria
boolean
C0243161 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
Peripheral edema
Item
peripheral oedema
boolean
C0085649 (UMLS CUI [1])
Nocturnal cough
Item
nocturnal cough
boolean
C0231912 (UMLS CUI [1])
Dyspnea on exertion
Item
dyspnoea at exercise
boolean
C0231807 (UMLS CUI [1])
Hepatomegaly
Item
hepatomegaly
boolean
C0019209 (UMLS CUI [1])
Pleural effusion
Item
pleural effusion
boolean
C0032227 (UMLS CUI [1])
Tachycardia beats per minute
Item
tachycardia (defined as ≥ 100 beats per minute)
boolean
C0039231 (UMLS CUI [1,1])
C0439385 (UMLS CUI [1,2])
Heart failure | Criteria Main Quantity | Criteria Secondary Quantity
Item
heart failure if: presence of 2 major criteria or 1 major + 2 minor criteria
boolean
C0018801 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0243161 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Echocardiography: left ventricular ejection fraction Timespan
Item
2. lvef ≥ 45% by echocardiography within 72h
boolean
C2097013 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
BNP | NT-proBNP
Item
3. bnp > 100 ng/l or nt-probnp > 300 ng/l
boolean
C1095989 (UMLS CUI [1])
C0754710 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Primary hypertrophic cardiomyopathy Associated with Heart Disease Infiltrating | Restrictive cardiomyopathy Associated with Heart Disease Infiltrating | Systemic disease Associated with Heart Disease Infiltrating
Item
evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease
boolean
C3665332 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0018799 (UMLS CUI [1,3])
C0332448 (UMLS CUI [1,4])
C0007196 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0018799 (UMLS CUI [2,3])
C0332448 (UMLS CUI [2,4])
C0442893 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0018799 (UMLS CUI [3,3])
C0332448 (UMLS CUI [3,4])
Right Heart Failure Cause Known | Independent of Left Ventricular Dysfunction
Item
known cause of right heart failure not related to left ventricular dysfunction
boolean
C0235527 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C0332291 (UMLS CUI [2,1])
C0242698 (UMLS CUI [2,2])
Pericardial constriction
Item
pericardial constriction
boolean
C0240709 (UMLS CUI [1])
Lung disease | Home oxygen supply Required
Item
clinically significant pulmonary disease, as evidenced by requirement of home oxygen.
boolean
C0024115 (UMLS CUI [1])
C0421203 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Kidney Failure, Chronic | Dialysis Required
Item
end-stage renal disease requiring dialysis
boolean
C0022661 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Biventricular Pacemaker | Cardiac Resynchronization Therapy
Item
bi-ventricular pacemaker (crt)
boolean
C1719274 (UMLS CUI [1])
C1167956 (UMLS CUI [2])
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