0 Evaluaciones
ID

43971

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02344199

Palabras clave

Versiones (2)
  1. 22/5/16 22/5/16 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Heart Failure NCT02344199

    Inglés

    Eligibility Heart Failure NCT02344199

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    eligible ages for the study:> 18 years
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients who are to receive eprelenone according to standard clinical practice
    Descripción

    eplerenone

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0961485
    patients with heart failure of ischemic / non-ischemic etiology
    Descripción

    Heart failure Etiology aspects Ischemic | Non-ischemic cardiomyopathy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [1,3]
    C0475224
    UMLS CUI [2]
    C0877438
    patients receiving standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2936643
    UMLS CUI [2]
    C0001645
    UMLS CUI [3,1]
    C0026565
    UMLS CUI [3,2]
    C3887460
    UMLS CUI [4,1]
    C0026538
    UMLS CUI [4,2]
    C3887460
    stable patients
    Descripción

    Patients Stable status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0205360
    patients with left ventricular dysfunction (lvef ≤ 40%)
    Descripción

    Ventricular Dysfunction, Left | Left ventricular ejection fraction

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0242698
    UMLS CUI [2]
    C0428772
    patients with clinically proven heart failure after recent myocardial infarction.
    Descripción

    Heart failure Post Recent myocardial infarction

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0687676
    UMLS CUI [1,3]
    C1998297
    patients who have fully understood the study protocol and signed the consent form
    Descripción

    Comprehension Study Protocol | Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [2]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients <18 years
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    hypersensitivity to eplerenone in any of the excipients
    Descripción

    Hypersensitivity eplerenone

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0961485
    patients with a serum potassium level> 5,0 mmol / l at the start of therapy
    Descripción

    Serum potassium measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0302353
    patients with moderate to severe renal impairment (creatinine clearance <50 ml / min)
    Descripción

    Has Moderate or Severe Renal Disease | Creatinine clearance measurement

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3829820
    UMLS CUI [2]
    C0373595
    patients with severe hepatic impairment (child-pugh class c)
    Descripción

    Hepatic impairment Severe | Child-Pugh Classification

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0948807
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C4050412
    patients taking diuretics guard potassium loss or strong inhibitors of cyp3a4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone)
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0354170
    UMLS CUI [2]
    C3850053
    UMLS CUI [3]
    C0064113
    UMLS CUI [4]
    C0022625
    UMLS CUI [5]
    C0292818
    UMLS CUI [6]
    C0525005
    UMLS CUI [7]
    C0055856
    UMLS CUI [8]
    C0907410
    UMLS CUI [9]
    C0068485
    patients who have not fully understood the study protocol and have not signed the consent form
    Descripción

    Comprehension Study Protocol | Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [2]
    C0021430
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    Similar models

    Eligibility Heart Failure NCT02344199

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
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