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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

Lien

https://clinicaltrials.gov/show/NCT01583881

Mots-clés

Versions (1)
  1. 27/11/2019 27/11/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 novembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Diastolic Heart Failure NCT01583881

    Anglais

    Eligibility Diastolic Heart Failure NCT01583881

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2960127 (Heart failure with normal ejection fraction)
    SNOMED
    446221000
    signs or symptoms of heart failure;
    Description

    Sign or Symptom Heart failure

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3540840 (Sign or Symptom)
    UMLS CUI [1,2]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    normal or mildly abnormal systolic lv function (lvef ≥ 50%);
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3266756 (Normal left ventricular systolic function)
    SNOMED
    1001000124104
    UMLS CUI [2,1]
    C1277187 (Left ventricular systolic dysfunction)
    SNOMED
    134401001
    UMLS CUI [2,2]
    C2945599 (Mild (qualifier value))
    SNOMED
    255604002
    LOINC
    LA6752-5
    UMLS CUI [3]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    evidence of diastolic lv dysfunction.
    Description

    Left ventricular diastolic dysfunction

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1273070 (Left ventricular diastolic dysfunction)
    SNOMED
    395704004
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020538 (Hypertensive disease)
    SNOMED
    38341003
    LOINC
    MTHU020789
    UMLS CUI [1,2]
    C4267671 (WHO classification)
    LOINC
    LP208914-4
    UMLS CUI [2]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [3]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [4,1]
    C0003364 (Antihypertensive Agents)
    SNOMED
    1182007
    LOINC
    LP31453-1
    UMLS CUI [4,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [5]
    C0855316 (Blood pressure ambulatory)
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    UMLS CUI [1,2]
    C0205360 (Stable status)
    SNOMED
    58158008
    LOINC
    LP73394-6
    UMLS CUI [1,3]
    C2960127 (Heart failure with normal ejection fraction)
    SNOMED
    446221000
    individual is ≥ 18 years of age.
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    known secondary cause of hypertension
    Description

    Secondary hypertension

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0155616 (Secondary hypertension)
    SNOMED
    31992008
    anatomy not eligible for renal denervation
    Description

    Anatomy Ineligible Renal artery denervation

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1384516 (Anatomy aspects)
    UMLS CUI [1,2]
    C1512714 (Ineligibility)
    UMLS CUI [1,3]
    C3544270 (Renal artery denervation)
    systolic heart failure (lvef < 50%)
    Description

    Heart Failure, Systolic | Left ventricular ejection fraction

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1135191 (Heart Failure, Systolic)
    SNOMED
    417996009
    UMLS CUI [2]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    individual has an estimated glomerular filtration rate (egfr) of < 30ml/min/1.73m2, using the mdrd calculation.
    Description

    Renal function GFR estimation by MDRD

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2170215 (renal function GFR estimation by MDRD)
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [1,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    UMLS CUI [1,3]
    C2945640 (compromise)
    UMLS CUI [1,4]
    C1113679 (patient safety)
    UMLS CUI [2,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [2,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    UMLS CUI [2,3]
    C2945640 (compromise)
    UMLS CUI [2,4]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [3]
    C0085096 (Peripheral Vascular Diseases)
    SNOMED
    400047006
    UMLS CUI [4]
    C0162871 (Aortic Aneurysm, Abdominal)
    SNOMED
    233985008
    UMLS CUI [5]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008
    UMLS CUI [6]
    C0040034 (Thrombocytopenia)
    SNOMED
    302215000
    UMLS CUI [7]
    C0684275 (Hemophilia, NOS)
    SNOMED
    90935002
    UMLS CUI [8]
    C0002871 (Anemia)
    SNOMED
    271737000
    LOINC
    MTHU020823
    UMLS CUI [9]
    C0003811 (Cardiac Arrhythmia)
    SNOMED
    698247007
    LOINC
    LA7414-1
    UMLS CUI [10]
    C0004238 (Atrial Fibrillation)
    SNOMED
    49436004
    individual is pregnant, nursing or planning to be pregnant.
    Description

    Pregnancy | Breast Feeding | Pregnancy, Planned

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    UMLS CUI [3]
    C0032992 (Pregnancy, Planned)
    SNOMED
    169565003
    Retour au début de la page

    Similar models

    Eligibility Diastolic Heart Failure NCT01583881

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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