ID

43971

Description

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

Link

https://clinicaltrials.gov/show/NCT02344199

Keywords

Versions (2)
  1. 5/22/16 5/22/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02344199

English

Eligibility Heart Failure NCT02344199

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

eplerenone

Data type

boolean

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

Heart failure Etiology aspects Ischemic | Non-ischemic cardiomyopathy

Data type

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
Description

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

Data type

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
Description

Patients Stable status

Data type

boolean

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

Ventricular Dysfunction, Left | Left ventricular ejection fraction

Data type

boolean

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

Heart failure Post Recent myocardial infarction

Data type

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
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients <18 years
Description

Age

Data type

boolean

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

Hypersensitivity eplerenone

Data type

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
Description

Serum potassium measurement

Data type

boolean

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

Has Moderate or Severe Renal Disease | Creatinine clearance measurement

Data type

boolean

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

Hepatic impairment Severe | Child-Pugh Classification

Data type

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)
Description

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

Data type

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
Description

Comprehension Study Protocol | Informed Consent

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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