ID

35924

Beschrijving

Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction; ODM derived from: https://clinicaltrials.gov/show/NCT02262078

Link

https://clinicaltrials.gov/show/NCT02262078

Trefwoorden

Versies (1)
  1. 04-04-19 04-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02262078

Engels

Eligibility Heart Failure NCT02262078

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
hfpef is defined by clinical symptoms of dyspnea and fatigue
Beschrijving

Heart failure with preserved ejection fraction | Symptoms Dyspnea | Symptoms Fatigue

Datatype

boolean

Alias
UMLS CUI [1]
C4509226
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0013404
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0015672
normal left ventricular ejection fraction (>/=50%)
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
and elevated left ventricular (lv) filling pressure at cardiac catheterization (defined as resting pulmonary capillary wedge pressure (pcwp)>15 mmhg and/or pcwp >/=25 mmhg during exercise).
Beschrijving

Ventricular filling pressure increased Left | Cardiac Catheterization Procedures | Pulmonary Capillary Wedge Pressure resting | Pulmonary Capillary Wedge Pressure Exercise

Datatype

boolean

Alias
UMLS CUI [1,1]
C1963871
UMLS CUI [1,2]
C0205091
UMLS CUI [2]
C0018795
UMLS CUI [3,1]
C0086879
UMLS CUI [3,2]
C0035253
UMLS CUI [4,1]
C0086879
UMLS CUI [4,2]
C0015259
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
systolic blood pressure <120 mmhg
Beschrijving

Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
prior nitrate therapy (within previous 2 weeks)
Beschrijving

Nitrates

Datatype

boolean

Alias
UMLS CUI [1]
C0028125
g6pd-deficiency
Beschrijving

Deficiency of glucose-6-phosphate dehydrogenase

Datatype

boolean

Alias
UMLS CUI [1]
C2939465
other "non-hfpef" specific causes of heart failure such as significant valvular disease (>moderate left-sided regurgitation, >mild stenosis)
Beschrijving

Cause Heart failure | Exception Heart failure with preserved ejection fraction [HFpEF] | Valvular disease | Regurgitation Left sided Moderate | Stenosis Mild

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C4509226
UMLS CUI [3]
C3258293
UMLS CUI [4,1]
C2004489
UMLS CUI [4,2]
C0443246
UMLS CUI [4,3]
C0205081
UMLS CUI [5,1]
C1261287
UMLS CUI [5,2]
C2945599
severe pulmonary disease
Beschrijving

Lung disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
unstable coronary disease or coronary spasm
Beschrijving

Coronary Artery Disease Unstable | Coronary Artery Spasm Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0010073
UMLS CUI [2,2]
C0443343
primary renal or hepatic disease
Beschrijving

Kidney Disease Primary | Liver disease Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205225
constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies, pregnancy.
Beschrijving

Pericarditis, Constrictive | Cardiomyopathy Infiltrating | Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0031048
UMLS CUI [2,1]
C0878544
UMLS CUI [2,2]
C0332448
UMLS CUI [3]
C0007196
UMLS CUI [4]
C0007194
UMLS CUI [5]
C0032961
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Similar models

Eligibility Heart Failure NCT02262078

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure with preserved ejection fraction | Symptoms Dyspnea | Symptoms Fatigue
Item
hfpef is defined by clinical symptoms of dyspnea and fatigue
boolean
C4509226 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0013404 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0015672 (UMLS CUI [3,2])
Left ventricular ejection fraction
Item
normal left ventricular ejection fraction (>/=50%)
boolean
C0428772 (UMLS CUI [1])
Ventricular filling pressure increased Left | Cardiac Catheterization Procedures | Pulmonary Capillary Wedge Pressure resting | Pulmonary Capillary Wedge Pressure Exercise
Item
and elevated left ventricular (lv) filling pressure at cardiac catheterization (defined as resting pulmonary capillary wedge pressure (pcwp)>15 mmhg and/or pcwp >/=25 mmhg during exercise).
boolean
C1963871 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
C0018795 (UMLS CUI [2])
C0086879 (UMLS CUI [3,1])
C0035253 (UMLS CUI [3,2])
C0086879 (UMLS CUI [4,1])
C0015259 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure
Item
systolic blood pressure <120 mmhg
boolean
C0871470 (UMLS CUI [1])
Nitrates
Item
prior nitrate therapy (within previous 2 weeks)
boolean
C0028125 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase
Item
g6pd-deficiency
boolean
C2939465 (UMLS CUI [1])
Cause Heart failure | Exception Heart failure with preserved ejection fraction [HFpEF] | Valvular disease | Regurgitation Left sided Moderate | Stenosis Mild
Item
other "non-hfpef" specific causes of heart failure such as significant valvular disease (>moderate left-sided regurgitation, >mild stenosis)
boolean
C0015127 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C4509226 (UMLS CUI [2,2])
C3258293 (UMLS CUI [3])
C2004489 (UMLS CUI [4,1])
C0443246 (UMLS CUI [4,2])
C0205081 (UMLS CUI [4,3])
C1261287 (UMLS CUI [5,1])
C2945599 (UMLS CUI [5,2])
Lung disease Severe
Item
severe pulmonary disease
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Coronary Artery Disease Unstable | Coronary Artery Spasm Unstable
Item
unstable coronary disease or coronary spasm
boolean
C1956346 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0010073 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Kidney Disease Primary | Liver disease Primary
Item
primary renal or hepatic disease
boolean
C0022658 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Pericarditis, Constrictive | Cardiomyopathy Infiltrating | Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Pregnancy
Item
constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies, pregnancy.
boolean
C0031048 (UMLS CUI [1])
C0878544 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
C0007196 (UMLS CUI [3])
C0007194 (UMLS CUI [4])
C0032961 (UMLS CUI [5])
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