ID

12607

Description

Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF; ODM derived from: https://clinicaltrials.gov/show/NCT02007720

Link

https://clinicaltrials.gov/show/NCT02007720

Keywords

Versions (1)
  1. 12/4/15 12/4/15 -
Uploaded on

December 4, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Heart Failure NCT02007720

English

Eligibility Acute Heart Failure NCT02007720

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female ≥ 18 years of age,
Description

Patient age and sex

Data type

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
hospitalized for ahf; ahf is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
Description

hospitalized for ahf

Data type

boolean

Alias
UMLS CUI [1,1]
C0264714
UMLS CUI [1,2]
C0870668
dyspnea at rest or with minimal exertion
Description

dyspnea at rest or with minimal exertion

Data type

boolean

Alias
UMLS CUI [1,1]
C0013404
UMLS CUI [1,2]
C0231807
pulmonary congestion on chest x-ray,
Description

pulmonary congestion

Data type

boolean

Alias
UMLS CUI [1]
C0242073
brain natriuretic peptide (bnp) ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
Description

brain natriuretic peptide (bnp) ≥350 pg/ml or nt-probnp ≥1,400 pg/ml

Data type

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
systolic bp ≥125 mmhg at the start and at the end of screening
Description

systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
Description

able to be randomized within 16 hours from presentation to the hospital,

Data type

boolean

Alias
UMLS CUI [1]
C1320532
received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute hf episode
Description

received intravenous furosemide

Data type

boolean

Alias
UMLS CUI [1,1]
C0354100
UMLS CUI [1,2]
C1391960
renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75ml/min/1.73m2, calculated using the modification of diet in renal disease formula (or modified smdrd formula according to specific ethnic groups and local practice guidelines).
Description

renal impairment

Data type

boolean

Alias
UMLS CUI [1]
C1565489
with body weight ≤ 160 kg
Description

body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
dyspnea primarily due to non-cardiac causes
Description

dyspnea primarily due to non-cardiac causes

Data type

boolean

Alias
UMLS CUI [1]
C0013404
temperature >38.5°c (oral or equivalent), sepsis, active and clinically significant infection requiring iv anti-microbial treatment or known presence or evidence of human immunodeficiency virus (hiv) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
Description

temperature >38.5°c (oral or equivalent), sepsis, active and clinically significant infection

Data type

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2]
C0009450
clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
Description

acute coronary syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
ahf due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
Description

significant arrhythmias

Data type

boolean

Alias
UMLS CUI [1]
C0003811
hepatic disease unrelated to heart failure etiology and as determined by any one of the following: ast and/or alt values exceeding 3 x uln and/or bilirubin > 1.5 x uln at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic hepatitis b (presence of hepatitis b surface antigen production: positive hbsag), or chronic hepatitis c infection (presence of hepatitis c genetic replication: positive hepatitis c viral rna, based on history and/or clinical findings, including laboratory results obtained during screening period).
Description

hepatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmhg on prior or current echocardiogram), and severe mitral stenosis
Description

significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C1960707
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
other protocol defined inclusion/exclusion criteria may apply.
Description

other protocol defined inclusion/exclusion criteria may apply

Data type

boolean

Alias
UMLS CUI [1]
C0205394
UMLS CUI [2]
C1516637
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Similar models

Eligibility Acute Heart Failure NCT02007720

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient age and sex
Item
male or female ≥ 18 years of age,
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
hospitalized for ahf
Item
hospitalized for ahf; ahf is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
boolean
C0264714 (UMLS CUI [1,1])
C0870668 (UMLS CUI [1,2])
dyspnea at rest or with minimal exertion
Item
dyspnea at rest or with minimal exertion
boolean
C0013404 (UMLS CUI [1,1])
C0231807 (UMLS CUI [1,2])
pulmonary congestion
Item
pulmonary congestion on chest x-ray,
boolean
C0242073 (UMLS CUI [1])
brain natriuretic peptide (bnp) ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
Item
brain natriuretic peptide (bnp) ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
systolic blood pressure
Item
systolic bp ≥125 mmhg at the start and at the end of screening
boolean
C0871470 (UMLS CUI [1])
able to be randomized within 16 hours from presentation to the hospital,
Item
able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
boolean
C1320532 (UMLS CUI [1])
received intravenous furosemide
Item
received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute hf episode
boolean
C0354100 (UMLS CUI [1,1])
C1391960 (UMLS CUI [1,2])
renal impairment
Item
renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75ml/min/1.73m2, calculated using the modification of diet in renal disease formula (or modified smdrd formula according to specific ethnic groups and local practice guidelines).
boolean
C1565489 (UMLS CUI [1])
body weight
Item
with body weight ≤ 160 kg
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
dyspnea primarily due to non-cardiac causes
Item
dyspnea primarily due to non-cardiac causes
boolean
C0013404 (UMLS CUI [1])
temperature >38.5°c (oral or equivalent), sepsis, active and clinically significant infection
Item
temperature >38.5°c (oral or equivalent), sepsis, active and clinically significant infection requiring iv anti-microbial treatment or known presence or evidence of human immunodeficiency virus (hiv) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
boolean
C0015967 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
acute coronary syndrome
Item
clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
boolean
C0948089 (UMLS CUI [1])
significant arrhythmias
Item
ahf due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
boolean
C0003811 (UMLS CUI [1])
hepatic disease
Item
hepatic disease unrelated to heart failure etiology and as determined by any one of the following: ast and/or alt values exceeding 3 x uln and/or bilirubin > 1.5 x uln at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic hepatitis b (presence of hepatitis b surface antigen production: positive hbsag), or chronic hepatitis c infection (presence of hepatitis c genetic replication: positive hepatitis c viral rna, based on history and/or clinical findings, including laboratory results obtained during screening period).
boolean
C0023895 (UMLS CUI [1])
significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy
Item
significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmhg on prior or current echocardiogram), and severe mitral stenosis
boolean
C0007194 (UMLS CUI [1])
C1960707 (UMLS CUI [2])
malignancy
Item
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year
boolean
C0006826 (UMLS CUI [1])
other protocol defined inclusion/exclusion criteria may apply
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C0205394 (UMLS CUI [1])
C1516637 (UMLS CUI [2])
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