ID

24181

Description

An Exploratory Study of Nesiritide in Participants With Acute Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00490724

Lien

https://clinicaltrials.gov/show/NCT00490724

Mots-clés

Versions (1)
  1. 27/07/2017 27/07/2017 -
Téléchargé le

27 juillet 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00490724

Anglais

Eligibility Heart Failure, Congestive NCT00490724

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with acute heart failure (including acute exacerbation of chronic heart failure) requiring hospitalization whose placement of right-heart catheter (flexible, tube-like tool used to take fluids out or put fluids into the body) is judged to be possible and useful for treatment
Description

Heart failure Hospitalization Required | Chronic heart failure Exacerbation | Catheterization of right heart Possible | Catheterization of right heart Useful

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1708385
UMLS CUI [2,1]
C0264716
UMLS CUI [2,2]
C4086268
UMLS CUI [3,1]
C0189896
UMLS CUI [3,2]
C0332149
UMLS CUI [4,1]
C0189896
UMLS CUI [4,2]
C3827682
participants with findings of pulmonary (having to do with the lungs) congestion on a chest x-ray (an image of a site produced on photographic film by x-rays passing through the site) film taken within 12 hours before starting the treatment
Description

Pulmonary congestion Chest X-ray

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242073
UMLS CUI [1,2]
C0039985
participants with 2 systolic blood pressure (sbp: refers to blood pressure [pressure of the blood on the arteries and other blood vessel] when the heart beats while pumping blood) values greater than or equal to 100 millimeters of mercury (mmhg) measured at an interval of at least 15 minutes in the hemodynamic (related to blood flow) assessment in observation period
Description

Systolic Pressure Measurement Quantity | Assessment Hemodynamic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0019010
in a hemodynamic assessment in observation period, participants with 2 pulmonary capillary wedge pressure (pcwp [if it is not available, pulmonary arterial diastolic pressure {padp}]) values greater than or equal to 18 mmhg measured at an interval of at least 15 minutes and the second measurement value is within positive 20 percent (%) and negative 20% compared with the first 1
Description

Assessment Hemodynamic | Pulmonary Capillary Wedge Pressure Measurement Quantity | Pulmonary artery diastolic pressure Measurement Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0019010
UMLS CUI [2,1]
C0086879
UMLS CUI [2,2]
C0242485
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0428644
UMLS CUI [3,2]
C0242485
UMLS CUI [3,3]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with severe (very serious, life threatening) hepatic (to do with liver) impairment or renal (to do with kidney) impairment, cancer (abnormal tissue that grows and spreads in the body until it kills), or malignant (cancerous) tumor (a mass in a specific area)
Description

Hepatic impairment Severe | Hepatic impairment Life Threatening | Renal Insufficiency | Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C2826244
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0006826
participants who are or may be pregnant or breast-feeding
Description

Pregnancy | Breast Feeding | Possible pregnancy | Breast Feeding Possible

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0425965
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0332149
participants receiving non-invasive (puncture, opening or cutting of the skin) positive pressure ventilation (nippv) or scheduled to receive this during the study period
Description

Non-invasive positive pressure (NIPPV) | Puncture | Opening of skin | Cutting Procedures on the Skin | Non-invasive positive pressure (NIPPV) Scheduled

Type de données

boolean

Alias
UMLS CUI [1]
C1455871
UMLS CUI [2]
C0034117
UMLS CUI [3]
C0411659
UMLS CUI [4]
C0695173
UMLS CUI [5,1]
C1455871
UMLS CUI [5,2]
C0205539
participants who received treatment with another investigational product within 4 weeks before the initiation of investigational treatment or who were enrolled in a clinical study of nesiritide in the past
Description

Investigational New Drugs | Study Subject Participation Status | Nesiritide

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0054015
participants who received prohibited concomitant medications within 3 hours before the initiation of investigational treatment or those who are receiving such a medication
Description

Illicit drug use

Type de données

boolean

Alias
UMLS CUI [1]
C0281875
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Similar models

Eligibility Heart Failure, Congestive NCT00490724

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Hospitalization Required | Chronic heart failure Exacerbation | Catheterization of right heart Possible | Catheterization of right heart Useful
Item
participants with acute heart failure (including acute exacerbation of chronic heart failure) requiring hospitalization whose placement of right-heart catheter (flexible, tube-like tool used to take fluids out or put fluids into the body) is judged to be possible and useful for treatment
boolean
C0018801 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
C0264716 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C0189896 (UMLS CUI [3,1])
C0332149 (UMLS CUI [3,2])
C0189896 (UMLS CUI [4,1])
C3827682 (UMLS CUI [4,2])
Pulmonary congestion Chest X-ray
Item
participants with findings of pulmonary (having to do with the lungs) congestion on a chest x-ray (an image of a site produced on photographic film by x-rays passing through the site) film taken within 12 hours before starting the treatment
boolean
C0242073 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Systolic Pressure Measurement Quantity | Assessment Hemodynamic
Item
participants with 2 systolic blood pressure (sbp: refers to blood pressure [pressure of the blood on the arteries and other blood vessel] when the heart beats while pumping blood) values greater than or equal to 100 millimeters of mercury (mmhg) measured at an interval of at least 15 minutes in the hemodynamic (related to blood flow) assessment in observation period
boolean
C0871470 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0019010 (UMLS CUI [2,2])
Assessment Hemodynamic | Pulmonary Capillary Wedge Pressure Measurement Quantity | Pulmonary artery diastolic pressure Measurement Quantity
Item
in a hemodynamic assessment in observation period, participants with 2 pulmonary capillary wedge pressure (pcwp [if it is not available, pulmonary arterial diastolic pressure {padp}]) values greater than or equal to 18 mmhg measured at an interval of at least 15 minutes and the second measurement value is within positive 20 percent (%) and negative 20% compared with the first 1
boolean
C1516048 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0086879 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0428644 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Hepatic impairment Severe | Hepatic impairment Life Threatening | Renal Insufficiency | Malignant Neoplasms
Item
participants with severe (very serious, life threatening) hepatic (to do with liver) impairment or renal (to do with kidney) impairment, cancer (abnormal tissue that grows and spreads in the body until it kills), or malignant (cancerous) tumor (a mass in a specific area)
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0948807 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
Pregnancy | Breast Feeding | Possible pregnancy | Breast Feeding Possible
Item
participants who are or may be pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
C0006147 (UMLS CUI [4,1])
C0332149 (UMLS CUI [4,2])
Non-invasive positive pressure (NIPPV) | Puncture | Opening of skin | Cutting Procedures on the Skin | Non-invasive positive pressure (NIPPV) Scheduled
Item
participants receiving non-invasive (puncture, opening or cutting of the skin) positive pressure ventilation (nippv) or scheduled to receive this during the study period
boolean
C1455871 (UMLS CUI [1])
C0034117 (UMLS CUI [2])
C0411659 (UMLS CUI [3])
C0695173 (UMLS CUI [4])
C1455871 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
Investigational New Drugs | Study Subject Participation Status | Nesiritide
Item
participants who received treatment with another investigational product within 4 weeks before the initiation of investigational treatment or who were enrolled in a clinical study of nesiritide in the past
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0054015 (UMLS CUI [3])
Illicit drug use
Item
participants who received prohibited concomitant medications within 3 hours before the initiation of investigational treatment or those who are receiving such a medication
boolean
C0281875 (UMLS CUI [1])
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