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ID

43971

Beschreibung

Eplerenone in Heart Failure Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02344199

Link

https://clinicaltrials.gov/show/NCT02344199

Stichworte

Versionen (2)
  1. 22.05.16 22.05.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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    Eligibility Heart Failure NCT02344199

    Englisch

    Eligibility Heart Failure NCT02344199

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    eligible ages for the study:> 18 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    patients who are to receive eprelenone according to standard clinical practice
    Beschreibung

    eplerenone

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0961485 (eplerenone)
    SNOMED
    398699008
    patients with heart failure of ischemic / non-ischemic etiology
    Beschreibung

    Heart failure Etiology aspects Ischemic | Non-ischemic cardiomyopathy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    UMLS CUI [1,2]
    C0015127 (Etiology aspects)
    UMLS CUI [1,3]
    C0475224 (Ischemic)
    SNOMED
    255426005
    UMLS CUI [2]
    C0877438 (Non-ischemic cardiomyopathy)
    patients receiving standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity
    Beschreibung

    Standard of Care | Adrenergic beta-Antagonists | Mortality Cardiovascular | Morbidity Cardiovascular

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2936643 (Standard of Care)
    UMLS CUI [2]
    C0001645 (Adrenergic beta-Antagonists)
    SNOMED
    373254001
    UMLS CUI [3,1]
    C0026565 (Mortality Vital Statistics)
    SNOMED
    409651001
    UMLS CUI [3,2]
    C3887460 (Cardiovascular)
    LOINC
    LP31409-3
    UMLS CUI [4,1]
    C0026538 (Morbidity - disease rate)
    UMLS CUI [4,2]
    C3887460 (Cardiovascular)
    LOINC
    LP31409-3
    stable patients
    Beschreibung

    Patients Stable status

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C0205360 (Stable status)
    SNOMED
    58158008
    LOINC
    LP73394-6
    patients with left ventricular dysfunction (lvef ≤ 40%)
    Beschreibung

    Ventricular Dysfunction, Left | Left ventricular ejection fraction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0242698 (Ventricular Dysfunction, Left)
    SNOMED
    275514001
    UMLS CUI [2]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    patients with clinically proven heart failure after recent myocardial infarction.
    Beschreibung

    Heart failure Post Recent myocardial infarction

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    UMLS CUI [1,2]
    C0687676 (Post)
    SNOMED
    288563008
    LOINC
    LP20512-7
    UMLS CUI [1,3]
    C1998297 (Recent myocardial infarction)
    SNOMED
    428752002
    patients who have fully understood the study protocol and signed the consent form
    Beschreibung

    Comprehension Study Protocol | Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [1,2]
    C2348563 (Study Protocol)
    UMLS CUI [2]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients <18 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    hypersensitivity to eplerenone in any of the excipients
    Beschreibung

    Hypersensitivity eplerenone

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0961485 (eplerenone)
    SNOMED
    398699008
    patients with a serum potassium level> 5,0 mmol / l at the start of therapy
    Beschreibung

    Serum potassium measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0302353 (Serum potassium measurement)
    SNOMED
    271236005
    patients with moderate to severe renal impairment (creatinine clearance <50 ml / min)
    Beschreibung

    Has Moderate or Severe Renal Disease | Creatinine clearance measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3829820 (Has Moderate or Severe Renal Disease)
    UMLS CUI [2]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    patients with severe hepatic impairment (child-pugh class c)
    Beschreibung

    Hepatic impairment Severe | Child-Pugh Classification

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0948807 (Hepatic impairment)
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2]
    C4050412 (Child-Pugh Clinical Classification)
    SNOMED
    3191000175106
    patients taking diuretics guard potassium loss or strong inhibitors of cyp3a4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone)
    Beschreibung

    Diuretics with potassium | Cytochrome P-450 CYP3A4 Inhibitors | Itraconazole | Ketoconazole | Ritonavir | Nelfinavir | Clarithromycin | telithromycin | nefazodone

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0354170 (diuretics with potassium)
    UMLS CUI [2]
    C3850053 (Cytochrome P-450 CYP3A4 Inhibitors)
    UMLS CUI [3]
    C0064113 (itraconazole)
    SNOMED
    96038009
    UMLS CUI [4]
    C0022625 (ketoconazole)
    SNOMED
    40232005
    UMLS CUI [5]
    C0292818 (ritonavir)
    SNOMED
    108693005
    UMLS CUI [6]
    C0525005 (nelfinavir)
    SNOMED
    108706004
    UMLS CUI [7]
    C0055856 (clarithromycin)
    SNOMED
    83999008
    UMLS CUI [8]
    C0907410 (telithromycin)
    SNOMED
    395260006
    UMLS CUI [9]
    C0068485 (nefazodone)
    SNOMED
    108435006
    patients who have not fully understood the study protocol and have not signed the consent form
    Beschreibung

    Comprehension Study Protocol | Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [1,2]
    C2348563 (Study Protocol)
    UMLS CUI [2]
    C0021430 (Informed Consent)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Heart Failure NCT02344199

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    eligible ages for the study:> 18 years
    boolean
    C0001779 (UMLS CUI [1])
    eplerenone
    Item
    patients who are to receive eprelenone according to standard clinical practice
    boolean
    C0961485 (UMLS CUI [1])
    Heart failure Etiology aspects Ischemic | Non-ischemic cardiomyopathy
    Item
    patients with heart failure of ischemic / non-ischemic etiology
    boolean
    C0018801 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C0475224 (UMLS CUI [1,3])
    C0877438 (UMLS CUI [2])
    Standard of Care | Adrenergic beta-Antagonists | Mortality Cardiovascular | Morbidity Cardiovascular
    Item
    patients receiving standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity
    boolean
    C2936643 (UMLS CUI [1])
    C0001645 (UMLS CUI [2])
    C0026565 (UMLS CUI [3,1])
    C3887460 (UMLS CUI [3,2])
    C0026538 (UMLS CUI [4,1])
    C3887460 (UMLS CUI [4,2])
    Patients Stable status
    Item
    stable patients
    boolean
    C0030705 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    Ventricular Dysfunction, Left | Left ventricular ejection fraction
    Item
    patients with left ventricular dysfunction (lvef ≤ 40%)
    boolean
    C0242698 (UMLS CUI [1])
    C0428772 (UMLS CUI [2])
    Heart failure Post Recent myocardial infarction
    Item
    patients with clinically proven heart failure after recent myocardial infarction.
    boolean
    C0018801 (UMLS CUI [1,1])
    C0687676 (UMLS CUI [1,2])
    C1998297 (UMLS CUI [1,3])
    Comprehension Study Protocol | Informed Consent
    Item
    patients who have fully understood the study protocol and signed the consent form
    boolean
    C0162340 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Age
    Item
    patients <18 years
    boolean
    C0001779 (UMLS CUI [1])
    Hypersensitivity eplerenone
    Item
    hypersensitivity to eplerenone in any of the excipients
    boolean
    C0020517 (UMLS CUI [1,1])
    C0961485 (UMLS CUI [1,2])
    Serum potassium measurement
    Item
    patients with a serum potassium level> 5,0 mmol / l at the start of therapy
    boolean
    C0302353 (UMLS CUI [1])
    Has Moderate or Severe Renal Disease | Creatinine clearance measurement
    Item
    patients with moderate to severe renal impairment (creatinine clearance <50 ml / min)
    boolean
    C3829820 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    Hepatic impairment Severe | Child-Pugh Classification
    Item
    patients with severe hepatic impairment (child-pugh class c)
    boolean
    C0948807 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C4050412 (UMLS CUI [2])
    Diuretics with potassium | Cytochrome P-450 CYP3A4 Inhibitors | Itraconazole | Ketoconazole | Ritonavir | Nelfinavir | Clarithromycin | telithromycin | nefazodone
    Item
    patients taking diuretics guard potassium loss or strong inhibitors of cyp3a4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone)
    boolean
    C0354170 (UMLS CUI [1])
    C3850053 (UMLS CUI [2])
    C0064113 (UMLS CUI [3])
    C0022625 (UMLS CUI [4])
    C0292818 (UMLS CUI [5])
    C0525005 (UMLS CUI [6])
    C0055856 (UMLS CUI [7])
    C0907410 (UMLS CUI [8])
    C0068485 (UMLS CUI [9])
    Comprehension Study Protocol | Informed Consent
    Item
    patients who have not fully understood the study protocol and have not signed the consent form
    boolean
    C0162340 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2])
    Zum Seitenanfang zurückkehren 

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