ID

29447

Beschreibung

Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF); ODM derived from: https://clinicaltrials.gov/show/NCT00400257

Link

https://clinicaltrials.gov/show/NCT00400257

Stichworte

Versionen (1)
  1. 25.03.18 25.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. März 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00400257

Englisch

Eligibility Heart Failure NCT00400257

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥60 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. have been insured with hba for 12 months or longer (protocol amended to remove this criteria and allow enrollment of the general public)
Beschreibung

Insurance Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C0449238
3. subjects at high-risk of subsequent development of heart failure; comprising at least one of:
Beschreibung

High risk of Heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0018801
prior myocardial infarction (mi) without known left ventricular (lv) dysfunction
Beschreibung

Myocardial Infarction | Left Ventricular Dysfunction Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0242698
UMLS CUI [2,2]
C0332197
current active ischemic heart disease
Beschreibung

Myocardial Ischemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0151744
prior cerebrovascular accident (cva)
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
known valvular heart disease without known lv dysfunction
Beschreibung

Heart valve disease | Left Ventricular Dysfunction Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2,1]
C0242698
UMLS CUI [2,2]
C0332197
atrial fibrillation
Beschreibung

Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
Beschreibung

Ventricular arrhythmia Resulting in Syncope | Ventricular arrhythmia Resulting in Presyncope

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0039070
UMLS CUI [2,1]
C0085612
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0700200
treated hypertension, of at least 2 years duration
Beschreibung

Hypertensive disease Treated Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0449238
treated diabetes mellitus, of at least 2 years duration
Beschreibung

Diabetes Mellitus Treated Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0449238
estimated glomerular filtration rate (egfr) <50ml/min
Beschreibung

Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C3811844
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known systolic or diastolic heart failure
Beschreibung

Heart Failure, Systolic | Heart Failure, Diastolic

Datentyp

boolean

Alias
UMLS CUI [1]
C1135191
UMLS CUI [2]
C1135196
2. symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
Beschreibung

Symptoms Suggestive of Heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C0018801
3. lv systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
Beschreibung

Left ventricular systolic dysfunction Echocardiography | Left ventricular diastolic dysfunction Echocardiography | Left ventricular systolic dysfunction Imaging | Left ventricular diastolic dysfunction Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277187
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C1273070
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C1277187
UMLS CUI [3,2]
C0079595
UMLS CUI [4,1]
C1273070
UMLS CUI [4,2]
C0079595
4. medications for treatment of heart failure such as ace inhibitors, angiotensin receptor blockers (arbs), beta-blockers or aldosterone antagonists. use of such medications for approved indications such as hypertension, post-mi management (without known lv dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)
Beschreibung

Pharmaceutical Preparations Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Aldosterone Antagonists | Pharmaceutical Preparations Hypertensive disease allowied| Pharmaceutical Preparations Myocardial Infarction allowed | Pharmaceutical Preparations Diabetic Nephropathy allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0002007
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0020538
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0027051
UMLS CUI [7,3]
C0683607
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C0011881
UMLS CUI [8,3]
C0683607
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Ähnliche Modelle

Eligibility Heart Failure NCT00400257

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥60 years
boolean
C0001779 (UMLS CUI [1])
Insurance Duration
Item
2. have been insured with hba for 12 months or longer (protocol amended to remove this criteria and allow enrollment of the general public)
boolean
C0021682 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
High risk of Heart failure
Item
3. subjects at high-risk of subsequent development of heart failure; comprising at least one of:
boolean
C0332167 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Myocardial Infarction | Left Ventricular Dysfunction Absent
Item
prior myocardial infarction (mi) without known left ventricular (lv) dysfunction
boolean
C0027051 (UMLS CUI [1])
C0242698 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Myocardial Ischemia
Item
current active ischemic heart disease
boolean
C0151744 (UMLS CUI [1])
Cerebrovascular accident
Item
prior cerebrovascular accident (cva)
boolean
C0038454 (UMLS CUI [1])
Heart valve disease | Left Ventricular Dysfunction Absent
Item
known valvular heart disease without known lv dysfunction
boolean
C0018824 (UMLS CUI [1])
C0242698 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Atrial Fibrillation
Item
atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Ventricular arrhythmia Resulting in Syncope | Ventricular arrhythmia Resulting in Presyncope
Item
ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
boolean
C0085612 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0039070 (UMLS CUI [1,3])
C0085612 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0700200 (UMLS CUI [2,3])
Hypertensive disease Treated Duration
Item
treated hypertension, of at least 2 years duration
boolean
C0020538 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Diabetes Mellitus Treated Duration
Item
treated diabetes mellitus, of at least 2 years duration
boolean
C0011849 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate (egfr) <50ml/min
boolean
C3811844 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Failure, Systolic | Heart Failure, Diastolic
Item
1. known systolic or diastolic heart failure
boolean
C1135191 (UMLS CUI [1])
C1135196 (UMLS CUI [2])
Symptoms Suggestive of Heart failure
Item
2. symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
boolean
C1457887 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Left ventricular systolic dysfunction Echocardiography | Left ventricular diastolic dysfunction Echocardiography | Left ventricular systolic dysfunction Imaging | Left ventricular diastolic dysfunction Imaging
Item
3. lv systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
boolean
C1277187 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C1273070 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C1277187 (UMLS CUI [3,1])
C0079595 (UMLS CUI [3,2])
C1273070 (UMLS CUI [4,1])
C0079595 (UMLS CUI [4,2])
Pharmaceutical Preparations Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Aldosterone Antagonists | Pharmaceutical Preparations Hypertensive disease allowied| Pharmaceutical Preparations Myocardial Infarction allowed | Pharmaceutical Preparations Diabetic Nephropathy allowed
Item
4. medications for treatment of heart failure such as ace inhibitors, angiotensin receptor blockers (arbs), beta-blockers or aldosterone antagonists. use of such medications for approved indications such as hypertension, post-mi management (without known lv dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)
boolean
C0013227 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0002007 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C0020538 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C0027051 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C0011881 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
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