0 Ratings
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

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November 27, 2019

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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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