ID

39537

Description

Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction; ODM derived from: https://clinicaltrials.gov/show/NCT02115230

Link

https://clinicaltrials.gov/show/NCT02115230

Keywords

Versions (1)
  1. 1/25/20 1/25/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 25, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure, Diastolic NCT02115230

English

Eligibility Heart Failure, Diastolic NCT02115230

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hypertension treated with at least 2 antihypertensive drugs;
Description

Hypertensive disease | Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
heart failure with a normal lv ejection fraction;
Description

Heart failure | Left ventricular ejection fraction Normal

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0205307
left ventricular hypertrophy (lv mass index > 96 g/m2 in women and > 116 g/m2 in men);
Description

Left Ventricular Hypertrophy | Left ventricular mass Index | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0149721
UMLS CUI [2,1]
C0455825
UMLS CUI [2,2]
C0918012
UMLS CUI [3]
C0079399
≥ 18 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known secondary cause of hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
uncontrolled blood pressure (≥ 180x110mmhg)
Description

Blood Pressure Uncontrolled | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0005824
unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
Description

Renal artery Anatomy Inappropriate | Renal Artery Stenosis | Prior Therapy Balloon | Prior Therapy Stent

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1548788
UMLS CUI [2]
C0035067
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0441144
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C0038257
advanced renal insufficiency (estimated glomerular filtration rate (gfr) < 30 ml/min/1.73 square meters)
Description

Renal Insufficiency Advanced | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C3811844
diabetes mellitus type 1
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
acute coronary syndrome or a cerebrovascular accident in the last 6 months
Description

Acute Coronary Syndrome | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
known other cause of respiratory dysfunction
Description

Cause Abnormal breathing

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1260922
previous lv systolic dysfunction (lvef < 50%)
Description

Left ventricular systolic dysfunction | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C1277187
UMLS CUI [2]
C0428772
restrictive cardiomyopathy or hypertrophic cardiomyopathy
Description

Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0007196
UMLS CUI [2]
C0007194
significant valvar dysfunction
Description

Valve Dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C1186983
UMLS CUI [1,2]
C3887504
atrial flutter or atrial fibrillation
Description

Atrial Flutter | Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004239
UMLS CUI [2]
C0004238
use of the oral anticoagulants
Description

Oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0354604
drug and alcohol dependence
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
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Similar models

Eligibility Heart Failure, Diastolic NCT02115230

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease | Antihypertensive Agents Quantity
Item
hypertension treated with at least 2 antihypertensive drugs;
boolean
C0020538 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Heart failure | Left ventricular ejection fraction Normal
Item
heart failure with a normal lv ejection fraction;
boolean
C0018801 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Left Ventricular Hypertrophy | Left ventricular mass Index | Gender
Item
left ventricular hypertrophy (lv mass index > 96 g/m2 in women and > 116 g/m2 in men);
boolean
C0149721 (UMLS CUI [1])
C0455825 (UMLS CUI [2,1])
C0918012 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
Age
Item
≥ 18 years of age;
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
known secondary cause of hypertension
boolean
C0155616 (UMLS CUI [1])
Blood Pressure Uncontrolled | Blood pressure determination
Item
uncontrolled blood pressure (≥ 180x110mmhg)
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0005824 (UMLS CUI [2])
Renal artery Anatomy Inappropriate | Renal Artery Stenosis | Prior Therapy Balloon | Prior Therapy Stent
Item
unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
boolean
C0035065 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0035067 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C0441144 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0038257 (UMLS CUI [4,2])
Renal Insufficiency Advanced | Estimated Glomerular Filtration Rate
Item
advanced renal insufficiency (estimated glomerular filtration rate (gfr) < 30 ml/min/1.73 square meters)
boolean
C1565489 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
diabetes mellitus type 1
boolean
C0011854 (UMLS CUI [1])
Acute Coronary Syndrome | Cerebrovascular accident
Item
acute coronary syndrome or a cerebrovascular accident in the last 6 months
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Cause Abnormal breathing
Item
known other cause of respiratory dysfunction
boolean
C0015127 (UMLS CUI [1,1])
C1260922 (UMLS CUI [1,2])
Left ventricular systolic dysfunction | Left ventricular ejection fraction
Item
previous lv systolic dysfunction (lvef < 50%)
boolean
C1277187 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy
Item
restrictive cardiomyopathy or hypertrophic cardiomyopathy
boolean
C0007196 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
Valve Dysfunction
Item
significant valvar dysfunction
boolean
C1186983 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
Atrial Flutter | Atrial Fibrillation
Item
atrial flutter or atrial fibrillation
boolean
C0004239 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
Oral anticoagulants
Item
use of the oral anticoagulants
boolean
C0354604 (UMLS CUI [1])
Substance Dependence
Item
drug and alcohol dependence
boolean
C0038580 (UMLS CUI [1])
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