ID

12575

Description

Acute Congestive Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01885403

Link

https://clinicaltrials.gov/show/NCT01885403

Keywords

Versions (1)
  1. 12/2/15 12/2/15 -
Uploaded on

December 2, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Decompensated Heart Failure (ADHF) NCT01885403

English

Eligibility Acute Decompensated Heart Failure (ADHF) NCT01885403

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, ages 18-75
Description

Patient sex and age

Data type

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
able and willing to provide written informed consent or not able to give informed consent because of mechanical respiration
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of acute or chronic decompensated heart failure with pulmonary congestion or edema
Description

decompensated heart failure with pulmonary congestion or edema

Data type

boolean

Alias
UMLS CUI [1]
C0581377
UMLS CUI [2]
C0242073
systolic blood pressure >80 mm hg at time of enrollment
Description

systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
resting pulse oximetry (spo2) at the time of enrollment of at least 88 percent at 21 percent iron oxides (feo2)
Description

resting pulse oximetry (spo2) at the time of enrollment of at least 88 percent at 21 percent iron oxides (feo2)

Data type

boolean

Alias
UMLS CUI [1]
C0428179
UMLS CUI [2]
C0428649
agreement to be measured with the study devices according to study protocol by patient or legal representative
Description

Protocol compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
left ventricular ejection fraction (lvef) < 40 percent in 3d- echocardiography
Description

left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active participation in another interventional research study
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
surgery of the upper airway, nose, sinus or middle ear within the last 90 days
Description

surgery of the upper airway, nose, sinus or middle ear within the last 90 days

Data type

boolean

Alias
UMLS CUI [1]
C0188964
UMLS CUI [2]
C0188970
UMLS CUI [3]
C0748725
UMLS CUI [4]
C2093310
major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study.
Description

for example, severe unstable chronic lung disease such as obstructive (fev1/fvc ≤ 30%), or restrictive (fvc < 50% predicted) lung disease, neuromuscular disease, cancer, or renal failure

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
unable to use pap therapies due to physical issues (e.g. facial structural abnormalities) or cognitive issues (e.g. dementia)
Description

unable to use pap therapies due to physical issues or cognitive issues

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
participants in whom positive airway pressure (pap) therapy is medically contraindicated.
Description

positive airway pressure (pap) therapy contraindicated

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1301624
uncontrolled hypertension (systolic ≥200 mm hg/diastolic ≥120 mm hg)
Description

uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0020538
pregnancy
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0549206
lactation
Description

lactation

Data type

boolean

Alias
UMLS CUI [1]
C0006147
implanted pacemaker / cardiac resynchronization therapy (crt) / implantable cardioverter-defibrillator (icd) except for medtronic devices with opti vol algorithm
Description

crt or icd therapy

Data type

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C1167956
incompetent patients or patients who, in the judgment of the investigator, are too unstable or are otherwise not capable of performing study procedures
Description

Patients not capable of performing study procedures

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
postpartum cardiomyopathy
Description

postpartum cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0269972
Hypertrophic cardiomyopathy (obstructive or non-obstructive)
Description

Hypertrophic cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0007194
primary mitral valve stenosis
Description

mitral valve stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0026269
patients requiring more than 50 percent supplemental oxygen or patients requiring more than 4 lpm oxygen
Description

supplemental oxygen

Data type

boolean

Alias
UMLS CUI [1]
C2016153
patients with persistent ventricular arrhythmias
Description

(premature ventricular coupling, periods of ventricular tachycardia)

Data type

boolean

Alias
UMLS CUI [1]
C0085612
patients chronically classified (prior to admission) as new york heart association (nyha) class iv or american heart association class d heart failure
Description

new york heart association (nyha) class iv or american heart association class d heart failure

Data type

boolean

Alias
UMLS CUI [1]
C1536133
UMLS CUI [2]
C3272276
patients with glomerular filtration rate (gfr) <30 or obligatory dialysis
Description

patients with glomerular filtration rate (gfr) <30 or obligatory dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0853068
UMLS CUI [2]
C0011946
resting respiratory rate >30 breaths per minute
Description

resting respiratory rate

Data type

boolean

Alias
UMLS CUI [1]
C0231835
patients requiring mechanical ventilation or patients with an artificial airway (endotracheal or tracheostomy tube)
Description

mechanical ventilation or patients with an artificial airway

Data type

boolean

Alias
UMLS CUI [1]
C0178987
UMLS CUI [2]
C0199470
patients with carbon monoxide toxicity
Description

carbon monoxide toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0007020
patients with severe sepsis
Description

(defined as also an organ dysfunction due to an infection according to the guidelines of the german association of sepsis, february 2010)

Data type

boolean

Alias
UMLS CUI [1]
C1719672
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Similar models

Eligibility Acute Decompensated Heart Failure (ADHF) NCT01885403

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient sex and age
Item
males and females, ages 18-75
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
informed consent
Item
able and willing to provide written informed consent or not able to give informed consent because of mechanical respiration
boolean
C0021430 (UMLS CUI [1])
decompensated heart failure with pulmonary congestion or edema
Item
diagnosis of acute or chronic decompensated heart failure with pulmonary congestion or edema
boolean
C0581377 (UMLS CUI [1])
C0242073 (UMLS CUI [2])
systolic blood pressure
Item
systolic blood pressure >80 mm hg at time of enrollment
boolean
C0871470 (UMLS CUI [1])
resting pulse oximetry (spo2) at the time of enrollment of at least 88 percent at 21 percent iron oxides (feo2)
Item
resting pulse oximetry (spo2) at the time of enrollment of at least 88 percent at 21 percent iron oxides (feo2)
boolean
C0428179 (UMLS CUI [1])
C0428649 (UMLS CUI [2])
Protocol compliance
Item
agreement to be measured with the study devices according to study protocol by patient or legal representative
boolean
C1321605 (UMLS CUI [1])
left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) < 40 percent in 3d- echocardiography
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
study subject participation status
Item
active participation in another interventional research study
boolean
C2348568 (UMLS CUI [1])
surgery of the upper airway, nose, sinus or middle ear within the last 90 days
Item
surgery of the upper airway, nose, sinus or middle ear within the last 90 days
boolean
C0188964 (UMLS CUI [1])
C0188970 (UMLS CUI [2])
C0748725 (UMLS CUI [3])
C2093310 (UMLS CUI [4])
major medical or psychiatric condition that would interfere with the demands of the study
Item
major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study.
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
unable to use pap therapies due to physical issues or cognitive issues
Item
unable to use pap therapies due to physical issues (e.g. facial structural abnormalities) or cognitive issues (e.g. dementia)
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
positive airway pressure (pap) therapy contraindicated
Item
participants in whom positive airway pressure (pap) therapy is medically contraindicated.
boolean
C0009488 (UMLS CUI [1])
C1301624 (UMLS CUI [2])
uncontrolled hypertension
Item
uncontrolled hypertension (systolic ≥200 mm hg/diastolic ≥120 mm hg)
boolean
C0009488 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
pregnancy
Item
pregnancy
boolean
C0549206 (UMLS CUI [1])
lactation
Item
lactation
boolean
C0006147 (UMLS CUI [1])
crt or icd therapy
Item
implanted pacemaker / cardiac resynchronization therapy (crt) / implantable cardioverter-defibrillator (icd) except for medtronic devices with opti vol algorithm
boolean
C0162589 (UMLS CUI [1])
C1167956 (UMLS CUI [2])
Patients not capable of performing study procedures
Item
incompetent patients or patients who, in the judgment of the investigator, are too unstable or are otherwise not capable of performing study procedures
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
postpartum cardiomyopathy
Item
postpartum cardiomyopathy
boolean
C0269972 (UMLS CUI [1])
Hypertrophic cardiomyopathy
Item
Hypertrophic cardiomyopathy (obstructive or non-obstructive)
boolean
C0007194 (UMLS CUI [1])
mitral valve stenosis
Item
primary mitral valve stenosis
boolean
C0026269 (UMLS CUI [1])
supplemental oxygen
Item
patients requiring more than 50 percent supplemental oxygen or patients requiring more than 4 lpm oxygen
boolean
C2016153 (UMLS CUI [1])
ventricular arrhythmias
Item
patients with persistent ventricular arrhythmias
boolean
C0085612 (UMLS CUI [1])
new york heart association (nyha) class iv or american heart association class d heart failure
Item
patients chronically classified (prior to admission) as new york heart association (nyha) class iv or american heart association class d heart failure
boolean
C1536133 (UMLS CUI [1])
C3272276 (UMLS CUI [2])
patients with glomerular filtration rate (gfr) <30 or obligatory dialysis
Item
patients with glomerular filtration rate (gfr) <30 or obligatory dialysis
boolean
C0853068 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
resting respiratory rate
Item
resting respiratory rate >30 breaths per minute
boolean
C0231835 (UMLS CUI [1])
mechanical ventilation or patients with an artificial airway
Item
patients requiring mechanical ventilation or patients with an artificial airway (endotracheal or tracheostomy tube)
boolean
C0178987 (UMLS CUI [1])
C0199470 (UMLS CUI [2])
carbon monoxide toxicity
Item
patients with carbon monoxide toxicity
boolean
C0007020 (UMLS CUI [1])
severe sepsis
Item
patients with severe sepsis
boolean
C1719672 (UMLS CUI [1])
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