ID

44692

Beschrijving

Use of Nesiritide in the Management of Acute Diastolic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00083772

Link

https://clinicaltrials.gov/show/NCT00083772

Trefwoorden

  1. 12-09-16 12-09-16 -
  2. 27-09-21 27-09-21 -
Geüploaded op

27 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Heart Failure NCT00083772

Eligibility Heart Failure NCT00083772

Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 85 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by cxr
Beschrijving

Acute heart failure | Fatigue - symptom | Dyspnea | Edema | Fluid overload Evidence Physical | Pulmonary Edema | Plain chest X-ray

Datatype

boolean

Alias
UMLS CUI [1]
C0264714
UMLS CUI [2]
C0015672
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0013604
UMLS CUI [5,1]
C0546817
UMLS CUI [5,2]
C3887511
UMLS CUI [5,3]
C0205485
UMLS CUI [6]
C0034063
UMLS CUI [7]
C0039985
lvef > or = 40% on recent (< or = 1 month) echo or muga
Beschrijving

Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0521317
nyha class iii or iv on admission
Beschrijving

New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
baseline systolic blood pressure > 90 mm hg
Beschrijving

Systolic Pressure Baseline

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1442488
baseline bnp level > 100 pg/ml
Beschrijving

BNP Baseline

Datatype

boolean

Alias
UMLS CUI [1,1]
C1095989
UMLS CUI [1,2]
C1442488
able to sign informed consent and return for follow-up assessments
Beschrijving

Informed Consent | Follow-up Compliance behavior

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1321605
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with clinically significant hypotension (defined as a systolic blood pressure (sbp) <90 mm hg)
Beschrijving

Hypotension Clinical Significance | Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0871470
active infection/sepsis as defined by fever > 101.5 f, currently on iv antibiotics
Beschrijving

Communicable Disease | Sepsis | Fever Degrees fahrenheit | Intravenous antibiotic therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0243026
UMLS CUI [3,1]
C0015967
UMLS CUI [3,2]
C0456628
UMLS CUI [4]
C0559680
creatinine greater than 3.0 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
lv ejection fraction < 40% (must be done within the last 30 days prior to signing consent)
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
significant valvular disease or constrictive cardiomyopathy
Beschrijving

Valvular disease Significant | Restrictive cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0007196
severe thrombocytopenia (as defined by platelets less than 20,000) or inr > 1.6
Beschrijving

Thrombocytopenia Severe | Platelet Count measurement | INR

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0525032
hypersensitivity to nesiritide or any of its components.
Beschrijving

Hypersensitivity Nesiritide | Hypersensitivity Nesiritide Component

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0054015
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0054015
UMLS CUI [2,3]
C1705248
pulmonary capillary wedge pressure (pcwp) <16 mmhg
Beschrijving

Pulmonary Capillary Wedge Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0086879
if patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive.
Beschrijving

Childbearing Potential Pregnancy Test | Pregnancy test positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [2]
C0240802

Similar models

Eligibility Heart Failure NCT00083772

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 to 85 years old
boolean
C0001779 (UMLS CUI [1])
Acute heart failure | Fatigue - symptom | Dyspnea | Edema | Fluid overload Evidence Physical | Pulmonary Edema | Plain chest X-ray
Item
admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by cxr
boolean
C0264714 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
C0013404 (UMLS CUI [3])
C0013604 (UMLS CUI [4])
C0546817 (UMLS CUI [5,1])
C3887511 (UMLS CUI [5,2])
C0205485 (UMLS CUI [5,3])
C0034063 (UMLS CUI [6])
C0039985 (UMLS CUI [7])
Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning
Item
lvef > or = 40% on recent (< or = 1 month) echo or muga
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
New York Heart Association Classification
Item
nyha class iii or iv on admission
boolean
C1275491 (UMLS CUI [1])
Systolic Pressure Baseline
Item
baseline systolic blood pressure > 90 mm hg
boolean
C0871470 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
BNP Baseline
Item
baseline bnp level > 100 pg/ml
boolean
C1095989 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Informed Consent | Follow-up Compliance behavior
Item
able to sign informed consent and return for follow-up assessments
boolean
C0021430 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypotension Clinical Significance | Systolic Pressure
Item
patients with clinically significant hypotension (defined as a systolic blood pressure (sbp) <90 mm hg)
boolean
C0020649 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
Communicable Disease | Sepsis | Fever Degrees fahrenheit | Intravenous antibiotic therapy
Item
active infection/sepsis as defined by fever > 101.5 f, currently on iv antibiotics
boolean
C0009450 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C0015967 (UMLS CUI [3,1])
C0456628 (UMLS CUI [3,2])
C0559680 (UMLS CUI [4])
Creatinine measurement, serum
Item
creatinine greater than 3.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lv ejection fraction < 40% (must be done within the last 30 days prior to signing consent)
boolean
C0428772 (UMLS CUI [1])
Valvular disease Significant | Restrictive cardiomyopathy
Item
significant valvular disease or constrictive cardiomyopathy
boolean
C3258293 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0007196 (UMLS CUI [2])
Thrombocytopenia Severe | Platelet Count measurement | INR
Item
severe thrombocytopenia (as defined by platelets less than 20,000) or inr > 1.6
boolean
C0040034 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
Hypersensitivity Nesiritide | Hypersensitivity Nesiritide Component
Item
hypersensitivity to nesiritide or any of its components.
boolean
C0020517 (UMLS CUI [1,1])
C0054015 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0054015 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Pulmonary Capillary Wedge Pressure
Item
pulmonary capillary wedge pressure (pcwp) <16 mmhg
boolean
C0086879 (UMLS CUI [1])
Childbearing Potential Pregnancy Test | Pregnancy test positive
Item
if patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0240802 (UMLS CUI [2])

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