Eligibility Heart Failure NCT01973335

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StudyEvent: Eligibility
1. Eligibility Heart Failure NCT01973335

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age | Informed Consent

Item

older than 18 years and able to give informed consent

boolean

C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])

Decompensated cardiac failure Recent

Item

clinical diagnosis of acute decompensated heart failure within the previous 8 h

boolean

C0581377 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])

Sign or Symptom Quantity Congestion | Edema Chest X-ray | Ascites Chest X-ray | Jugular venous engorgement Chest X-ray | Pulmonary congestion Vascular Chest X-ray

Item

at least two clinical signs of congestion (edema, ascites, jugular venous distension, or pulmonary vascular congestion on chest radiography)

boolean

C3540840 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0700148 (UMLS CUI [1,3])
C0013604 (UMLS CUI [2,1])
C0039985 (UMLS CUI [2,2])
C0003962 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])
C0425687 (UMLS CUI [4,1])
C0039985 (UMLS CUI [4,2])
C0242073 (UMLS CUI [5,1])
C1801960 (UMLS CUI [5,2])
C0039985 (UMLS CUI [5,3])

Maintenance therapy | Loop Diuretics Oral | Bumetanide Dose | Equivalent Furosemide Dose | Equivalent Torsemide Dose

Item

maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide (1 mg bumetanide = 40 mg furosemide = 20 mg torsemide) for at least 1 month before hospital admission

boolean

C0677908 (UMLS CUI [1])
C0354100 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0006376 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205163 (UMLS CUI [4,1])
C0016860 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205163 (UMLS CUI [5,1])
C0076840 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])

N-Terminal ProB-type Natriuretic Peptide Measurement

Item

nt-probnp >1000 ng/l

boolean

C3272900 (UMLS CUI [1])

Left ventricular ejection fraction

Item

left ventricular ejection fraction <50%

boolean

C0428772 (UMLS CUI [1])

Criteria Quantity

Item

at least one out of three of the following criteria:

boolean

C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])

Serum sodium measurement

Item

serum sodium <136 mmol/l

boolean

C0523891 (UMLS CUI [1])

Urea to Creatinine Ratio Measurement | Comparison BUN/Creatinine ratio

Item

serum urea/creatinine ratio >50 (comparable to a bun/creatinine ratio >25)

boolean

C3272926 (UMLS CUI [1])
C1707455 (UMLS CUI [2,1])
C0201922 (UMLS CUI [2,2])

Serum creatinine raised

Item

admission serum creatinine increased with >0.3 mg/dl compared to previous value within 3 months before admission

boolean

C0700225 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Heart Transplantation | Artificial Ventricle

Item

history of cardiac transplantation and/or ventricular assist device

boolean

C0018823 (UMLS CUI [1])
C0085842 (UMLS CUI [2])

Acute Coronary Syndrome | Chest Pain Typical | Electrocardiographic changes In addition to Troponin increased

Item

concurrent diagnosis of an acute coronary syndrome defined as typical chest pain and/or electrocardiographic changes in addition to a troponin rise >99th percentile

boolean

C0948089 (UMLS CUI [1])
C0008031 (UMLS CUI [2,1])
C3538928 (UMLS CUI [2,2])
C0855329 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C1141948 (UMLS CUI [3,3])

Mean blood pressure | Systolic Pressure

Item

mean arterial blood pressure <65 mmhg, or systolic blood pressure <90 mmhg at the moment of admission

boolean

C0428886 (UMLS CUI [1])
C0871470 (UMLS CUI [2])

Inotropic agent Intravenous | Vasoconstrictor Agents | Nitroprusside

Item

use of intravenous inotropes, vasopressors or nitroprusside at any time point during the study

boolean

C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0042397 (UMLS CUI [2])
C0028193 (UMLS CUI [3])

Estimated Glomerular Filtration Rate CKD-EPI

Item

a baseline estimated glomerular filtration rate <15 ml/min/1.73m² according to the chronic kidney disease epidemiology collaboration (ckd-epi) formula at the moment of inclusion

boolean

C3811844 (UMLS CUI [1,1])
C2964649 (UMLS CUI [1,2])

Renal Replacement Therapy | Ultrafiltration

Item

use of renal replacement therapy or ultrafiltration before study inclusion

boolean

C0206074 (UMLS CUI [1])
C0041612 (UMLS CUI [2])

Acetazolamide

Item

treatment with acetazolamide within the previous month

boolean

C0000981 (UMLS CUI [1])

Bumetanide Dose | Equivalent Dose

Item

treatment with ≥2 mg bumetanide or an equivalent dose during the index hospitalization before randomization

boolean

C0006376 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205163 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])

Diuretics | Vasopressin Antagonist | Mineralocorticoid Receptor Antagonists

Item

use of diuretics, vasopressin antagonists or mineralocorticoid receptor antagonist not specified by the protocol

boolean

C0012798 (UMLS CUI [1])
C3537128 (UMLS CUI [2])
C1579268 (UMLS CUI [3])

Exposure to Agent Nephrotoxic | Exposure to Contrast dye

Item

exposure to nephrotoxic agents (i.e. contrast dye) anticipated within 3 days

boolean

C0332157 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
C1514118 (UMLS CUI [1,3])
C0332157 (UMLS CUI [2,1])
C0742795 (UMLS CUI [2,2])

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Eligibility Heart Failure NCT01973335