ID

35942

Description

Safety and Effectiveness of SGLT-2 Inhibitors in Patients With Heart Failure and Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02397421

Link

https://clinicaltrials.gov/show/NCT02397421

Keywords

Versions (1)
  1. 4/5/19 4/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02397421

English

Eligibility Heart Failure NCT02397421

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
were previously diagnosed with type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
are diagnosed with nyha functional class i-ii hf with prior echocardiographic evidence of left ventricular systolic dysfunction (lvsd)
Description

Heart failure New York Heart Association Classification | Left ventricular systolic dysfunction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C1277187
UMLS CUI [2,2]
C0013516
on furosemide 40mg daily or less, or equivalent loop diuretic
Description

Furosemide U/day | Loop Diuretic Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0016860
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0354100
UMLS CUI [2,2]
C0205163
have stable hf symptoms for at least three months prior to consent
Description

Symptoms Stable Heart failure Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0018801
UMLS CUI [1,4]
C0449238
on stable therapy for hf for at least three months prior to consent
Description

Therapy Stable Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0018801
have not been hospitalised for hf for at least three months prior to consent
Description

Hospitalization Absent Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0018801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hepatic disease
Description

Liver disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
renal disease defined as chronic kidney disease (ckd) class 3 or worse (i.e. estimated glomerular filtration rate (egfr) <60ml/min)
Description

Kidney Disease | Chronic Kidney Disease Stage | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2,1]
C1561643
UMLS CUI [2,2]
C2074731
UMLS CUI [3]
C3811844
systolic bp <95mmhg at screening visit
Description

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
screening hba1c <6.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
unable to walk to perform cardio pulmonary exercise testing or 6mwt
Description

Lacking Able to walk Pulmonary exercise test | 6-Minute Walk Test Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [1,3]
C1096466
UMLS CUI [2,1]
C0430515
UMLS CUI [2,2]
C1299582
on insulin, meglitinides eg, repaglinide, or 2nd generation sulphonylureas, eg glipizide
Description

Insulin | Meglitinide | repaglinide | Sulfonylureas Generation second | Glipizide

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0065880
UMLS CUI [3]
C0246689
UMLS CUI [4,1]
C0038766
UMLS CUI [4,2]
C0079411
UMLS CUI [4,3]
C0205436
UMLS CUI [5]
C0017642
malignancy (receiving active treatment) or other life threatening diseases
Description

Malignant Neoplasm Treating | Life threatening illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1522326
UMLS CUI [2]
C3846017
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any contraindication to mri (e.g. claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
Description

Medical contraindication MRI | Claustrophobia | Metallic implant | Eye Injury, Penetrating | Exposure to Metal foreign body in eye region | Attention Medical Required

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0008909
UMLS CUI [3]
C3693688
UMLS CUI [4]
C0015409
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C0562528
UMLS CUI [6,1]
C0004268
UMLS CUI [6,2]
C0205476
UMLS CUI [6,3]
C1514873
patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
patients who are unable to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
any other reason considered by a study physician to be inappropriate for inclusion.
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Heart Failure NCT02397421

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
were previously diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Heart failure New York Heart Association Classification | Left ventricular systolic dysfunction Echocardiography
Item
are diagnosed with nyha functional class i-ii hf with prior echocardiographic evidence of left ventricular systolic dysfunction (lvsd)
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1277187 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Furosemide U/day | Loop Diuretic Equivalent
Item
on furosemide 40mg daily or less, or equivalent loop diuretic
boolean
C0016860 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0354100 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Symptoms Stable Heart failure Duration
Item
have stable hf symptoms for at least three months prior to consent
boolean
C1457887 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Therapy Stable Heart failure
Item
on stable therapy for hf for at least three months prior to consent
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Hospitalization Absent Heart failure
Item
have not been hospitalised for hf for at least three months prior to consent
boolean
C0019993 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Liver disease Severe
Item
severe hepatic disease
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Kidney Disease | Chronic Kidney Disease Stage | Estimated Glomerular Filtration Rate
Item
renal disease defined as chronic kidney disease (ckd) class 3 or worse (i.e. estimated glomerular filtration rate (egfr) <60ml/min)
boolean
C0022658 (UMLS CUI [1])
C1561643 (UMLS CUI [2,1])
C2074731 (UMLS CUI [2,2])
C3811844 (UMLS CUI [3])
Systolic Pressure
Item
systolic bp <95mmhg at screening visit
boolean
C0871470 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
screening hba1c <6.0%
boolean
C0474680 (UMLS CUI [1])
Lacking Able to walk Pulmonary exercise test | 6-Minute Walk Test Unable
Item
unable to walk to perform cardio pulmonary exercise testing or 6mwt
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C1096466 (UMLS CUI [1,3])
C0430515 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Insulin | Meglitinide | repaglinide | Sulfonylureas Generation second | Glipizide
Item
on insulin, meglitinides eg, repaglinide, or 2nd generation sulphonylureas, eg glipizide
boolean
C0021641 (UMLS CUI [1])
C0065880 (UMLS CUI [2])
C0246689 (UMLS CUI [3])
C0038766 (UMLS CUI [4,1])
C0079411 (UMLS CUI [4,2])
C0205436 (UMLS CUI [4,3])
C0017642 (UMLS CUI [5])
Malignant Neoplasm Treating | Life threatening illness
Item
malignancy (receiving active treatment) or other life threatening diseases
boolean
C0006826 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C3846017 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication MRI | Claustrophobia | Metallic implant | Eye Injury, Penetrating | Exposure to Metal foreign body in eye region | Attention Medical Required
Item
any contraindication to mri (e.g. claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
C0015409 (UMLS CUI [4])
C0332157 (UMLS CUI [5,1])
C0562528 (UMLS CUI [5,2])
C0004268 (UMLS CUI [6,1])
C0205476 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
Study Subject Participation Status | Investigational New Drugs
Item
patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Informed Consent Unable
Item
patients who are unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
any other reason considered by a study physician to be inappropriate for inclusion.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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