ID

39077

Description

Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction; ODM derived from: https://clinicaltrials.gov/show/NCT01583881

Link

https://clinicaltrials.gov/show/NCT01583881

Keywords

Versions (1)
  1. 11/27/19 11/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diastolic Heart Failure NCT01583881

English

Eligibility Diastolic Heart Failure NCT01583881

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
individual is diagnosed with heart failure with a normal lv ejection fraction. the diagnosis of hfnef requires the following conditions to be satisfied:
Description

Heart failure with normal ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C2960127
signs or symptoms of heart failure;
Description

Sign or Symptom Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0018801
normal or mildly abnormal systolic lv function (lvef ≥ 50%);
Description

Normal left ventricular systolic function | Left ventricular systolic dysfunction Mild | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C3266756
UMLS CUI [2,1]
C1277187
UMLS CUI [2,2]
C2945599
UMLS CUI [3]
C0428772
evidence of diastolic lv dysfunction.
Description

Left ventricular diastolic dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C1273070
individual should fulfill the diagnostic who criteria for hypertension: sbp > 140 mmhg and/or dbp > 90 mmhg, and is treated with at least 2 antihypertensive drugs. this treatment is expected to be maintained for at least 6 months. using this regimen the blood pressure should be adequately controlled (< 140/90mmhg by 24 hour ambulatory bp measurement).
Description

Hypertensive disease WHO classification | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity | Blood pressure ambulatory

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C4267671
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C1265611
UMLS CUI [5]
C0855316
individual is adhering to a stable drug regimen hfnef, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.
Description

Pharmacotherapy Stable Heart failure with normal ejection fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C2960127
individual is ≥ 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
anatomy not eligible for renal denervation
Description

Anatomy Ineligible Renal artery denervation

Data type

boolean

Alias
UMLS CUI [1,1]
C1384516
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C3544270
systolic heart failure (lvef < 50%)
Description

Heart Failure, Systolic | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C1135191
UMLS CUI [2]
C0428772
individual has an estimated glomerular filtration rate (egfr) of < 30ml/min/1.73m2, using the mdrd calculation.
Description

Renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C2170215
individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation).
Description

Medical condition Serious compromises Patient safety | Medical condition Serious compromises Clinical Trial | Peripheral Vascular Disease | Aortic Aneurysm, Abdominal | Blood Coagulation Disorders | Thrombocytopenia | Hemophilia | Anemia | Cardiac Arrhythmia | Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C0008976
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0162871
UMLS CUI [5]
C0005779
UMLS CUI [6]
C0040034
UMLS CUI [7]
C0684275
UMLS CUI [8]
C0002871
UMLS CUI [9]
C0003811
UMLS CUI [10]
C0004238
individual is pregnant, nursing or planning to be pregnant.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Diastolic Heart Failure NCT01583881

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure with normal ejection fraction
Item
individual is diagnosed with heart failure with a normal lv ejection fraction. the diagnosis of hfnef requires the following conditions to be satisfied:
boolean
C2960127 (UMLS CUI [1])
Sign or Symptom Heart failure
Item
signs or symptoms of heart failure;
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Normal left ventricular systolic function | Left ventricular systolic dysfunction Mild | Left ventricular ejection fraction
Item
normal or mildly abnormal systolic lv function (lvef ≥ 50%);
boolean
C3266756 (UMLS CUI [1])
C1277187 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
Left ventricular diastolic dysfunction
Item
evidence of diastolic lv dysfunction.
boolean
C1273070 (UMLS CUI [1])
Hypertensive disease WHO classification | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity | Blood pressure ambulatory
Item
individual should fulfill the diagnostic who criteria for hypertension: sbp > 140 mmhg and/or dbp > 90 mmhg, and is treated with at least 2 antihypertensive drugs. this treatment is expected to be maintained for at least 6 months. using this regimen the blood pressure should be adequately controlled (< 140/90mmhg by 24 hour ambulatory bp measurement).
boolean
C0020538 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0003364 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0855316 (UMLS CUI [5])
Pharmacotherapy Stable Heart failure with normal ejection fraction
Item
individual is adhering to a stable drug regimen hfnef, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C2960127 (UMLS CUI [1,3])
Age
Item
individual is ≥ 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])
Anatomy Ineligible Renal artery denervation
Item
anatomy not eligible for renal denervation
boolean
C1384516 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C3544270 (UMLS CUI [1,3])
Heart Failure, Systolic | Left ventricular ejection fraction
Item
systolic heart failure (lvef < 50%)
boolean
C1135191 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Renal function GFR estimation by MDRD
Item
individual has an estimated glomerular filtration rate (egfr) of < 30ml/min/1.73m2, using the mdrd calculation.
boolean
C2170215 (UMLS CUI [1])
Medical condition Serious compromises Patient safety | Medical condition Serious compromises Clinical Trial | Peripheral Vascular Disease | Aortic Aneurysm, Abdominal | Blood Coagulation Disorders | Thrombocytopenia | Hemophilia | Anemia | Cardiac Arrhythmia | Atrial Fibrillation
Item
individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation).
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0085096 (UMLS CUI [3])
C0162871 (UMLS CUI [4])
C0005779 (UMLS CUI [5])
C0040034 (UMLS CUI [6])
C0684275 (UMLS CUI [7])
C0002871 (UMLS CUI [8])
C0003811 (UMLS CUI [9])
C0004238 (UMLS CUI [10])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
individual is pregnant, nursing or planning to be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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