ID

41591

Description

The Role of Sleep Disordered Breathing in Heart Failure Admissions; ODM derived from: https://clinicaltrials.gov/show/NCT02505867

Lien

https://clinicaltrials.gov/show/NCT02505867

Mots-clés

Versions (1)
  1. 18/11/2020 18/11/2020 -
Détendeur de droits

see on clinicaltrials.gov

Téléchargé le

18 novembre 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Sleep Disordered Breathing in Heart Failure NCT02505867

Anglais

Eligibility Sleep Apnea Syndromes NCT02505867

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
admission diagnosis of heart failure and acute heart failure syndrome as defined by the following: a chief complaint of dyspnea or fatigue; elevated left ventricular pressure. elevated left ventricular pressure is indicated by at least one of the following: signs of volume overload pedal edema, crackles, consistent chest x-ray, increased measurement of left ventricular end-diastolic diameter or volume, or elevated bnp level.
Description

heart failure and acute heart failure syndrome defined by: chief complaint of dyspnea or fatigue; elevated left ventricular pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0264714
UMLS CUI [3,1]
C0277786
UMLS CUI [3,2]
C0013404
UMLS CUI [4,1]
C0277786
UMLS CUI [4,2]
C0015672
UMLS CUI [5,1]
C3163633
UMLS CUI [5,2]
C0456189
previously unrecognized or recognized but untreated sleep disordered breathing diagnosed or confirmed on attended inpatient sleep study during the index hospitalization with ahfs. sdb is defined as one of the following syndromes: 1. ahi>15 with more than 50% apneas being central (csa); or 2. ahi>30 events with more than 50% of the events being obstructive (severe osa) in patients with lvef <30%
Description

previously unrecognized and/or untreated SDB diagnosed or confirmed by polysomnography during hospitalization with ahfs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C4288068
UMLS CUI [1,3]
C0037315
UMLS CUI [1,4]
C0162701
UMLS CUI [1,5]
C0019993
UMLS CUI [1,6]
C0264714
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C0332155
UMLS CUI [2,3]
C0037315
UMLS CUI [2,4]
C0162701
UMLS CUI [2,5]
C0019993
UMLS CUI [2,6]
C0264714
projected length of stay >2 days on admission day to ensure uniformity of the underlying severity of the ahfs and to enable the introduction of the asv device and education
Description

expected length of stay

Type de données

boolean

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C0023303
lvef <45% within 1 year of admission. an echocardiogram may be performed to confirm the lvef during the hospitalization to determine eligibility.
Description

recent left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0428772
ongoing targeted treatment for heart failure during the current hospitalization including at least one of the following: iv diuretics, iv infusion of inotropes or vasodilators, or planned revascularization, or device therapy.
Description

ongoing targeted treatment for heart failure during current hospitalization including: iv diuretics, iv infusion of inotropes or vasodilators, or planned revascularization, or device therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C0018801
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0019993
UMLS CUI [2,1]
C0012798
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C0304509
UMLS CUI [3,2]
C1522726
UMLS CUI [4,1]
C1522726
UMLS CUI [4,2]
C0042402
UMLS CUI [5,1]
C1301732
UMLS CUI [5,2]
C0581603
UMLS CUI [6]
C1504335
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who were on supplemental oxygen for an indication other than sdb or heart failure prior to admission. these are patients who have chronic respiratory insufficiency.
Description

supplemental oxygen as prior therapy for indication other than sdb or heart failure (chronic respiratory insufficiency)

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C4534306
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C3146298
UMLS CUI [2,3]
C0037315
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C3146298
UMLS CUI [3,3]
C0018801
UMLS CUI [4]
C1998122
patients on treatment targeting csa or osa (asv, oxygen, or cpap); and patients who already provided and rejected positive airway pressure therapy due to intolerance of the pressure or the claustrophobia.
Description

on treatment targeting csa or osa and already provided and rejected positive airway pressure therapy due to intolerance of the pressure or claustrophobia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0520680
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0520679
UMLS CUI [3,1]
C0199451
UMLS CUI [3,2]
C1548437
UMLS CUI [3,3]
C1704410
UMLS CUI [3,4]
C0205160
UMLS CUI [4,1]
C0199451
UMLS CUI [4,2]
C1548437
UMLS CUI [4,3]
C0008909
cardiogenic shock and hemodynamic instability with map less than 55 mmhg off vasopressors, or concurrently on vasopressor treatment, left ventricular assist devices, or intra-aortic balloon pump. inotropic agents will not constitute an exclusion criterion. patients will be eligible once more stable off vasopressors.
Description

cardiogenic shock and hemodynamic instability with map less than 55 mmhg off vasopressors, or concurrently on vasopressor treatment, left ventricular assist devices, or intra-aortic balloon pump. inotropic agents will not constitute an exclusion criterion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036980
UMLS CUI [1,2]
C0428886
UMLS CUI [1,3]
C1518544
UMLS CUI [1,4]
C0042397
UMLS CUI [2,1]
C0948268
UMLS CUI [2,2]
C0428886
UMLS CUI [2,3]
C1518544
UMLS CUI [2,4]
C0042397
UMLS CUI [3,1]
C0036980
UMLS CUI [3,2]
C0428886
UMLS CUI [3,3]
C0042397
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0304509
UMLS CUI [5,1]
C0036980
UMLS CUI [5,2]
C0428886
UMLS CUI [5,3]
C0181598
UMLS CUI [6,1]
C0036980
UMLS CUI [6,2]
C0428886
UMLS CUI [6,3]
C0702122
UMLS CUI [7,1]
C0948268
UMLS CUI [7,2]
C0428886
UMLS CUI [7,3]
C0042397
UMLS CUI [8,1]
C0332300
UMLS CUI [8,2]
C0304509
UMLS CUI [9,1]
C0948268
UMLS CUI [9,2]
C0428886
UMLS CUI [9,3]
C0181598
UMLS CUI [10,1]
C0948268
UMLS CUI [10,2]
C0428886
UMLS CUI [10,3]
C0021860
acute respiratory failure or insufficiency defined by (pao2/fio2) ratio less than 250, or fio2 requirement more than 40%. patients are eligible to participate once their fio2 requirement is below 30%.
Description

acute respiratory failure or insufficiency defined by pao2/fio2 ratio or fio2 requirement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205178
UMLS CUI [1,2]
C1145670
UMLS CUI [2,1]
C0205178
UMLS CUI [2,2]
C0035229
UMLS CUI [3]
C4087239
UMLS CUI [4]
C0428167
overt neurological deficit or patients who arrived from a long-term care facility or expected to be discharged to one; and patients who have very poor functional outcome precluding ability to use the asv device independently
Description

overt neurological deficit or having arrived from or being expected to be dicharged to a long-term care facility and having poor functional outcome precluding ability for independent use of asv device

Type de données

boolean

Alias
UMLS CUI [1]
C0521654
UMLS CUI [2,1]
C2982691
UMLS CUI [2,2]
C1708733
UMLS CUI [3,1]
C1517001
UMLS CUI [3,2]
C0030685
UMLS CUI [3,3]
C1708733
UMLS CUI [4,1]
C2700379
UMLS CUI [4,2]
C1547647
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C1299583
UMLS CUI [4,5]
C4285752
UMLS CUI [4,6]
C0699733
renal failure requiring renal replacement therapy; patients will not be excluded if they were undergoing ultra-filtration for volume removal.
Description

renal failure requiring renal replacement therapy. not excluded for undergoing ultra-filtration for volume removal

Type de données

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0206074
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0041612
UMLS CUI [2,3]
C0449468
UMLS CUI [2,4]
C1883720
moderate to severe chronic obstructive lung disease (fev1/fvc < 55%).
Description

moderate to severe chronic obstructive lung disease (fev1/fvc < 55%)

Type de données

boolean

Alias
UMLS CUI [1,1]
C1299393
UMLS CUI [1,2]
C0024117
UMLS CUI [2]
C0429745
patients who are likely to receive heart transplant or left ventricular assist device (lvad) in the subsequent year. these are patients who have high standing on the transplant list during the index hospitalization or have a cardiothoracic evaluation for implantation of lvad.
Description

likely to receive heart transplant or left ventricular assist device (lvad) in the subsequent year

Type de données

boolean

Alias
UMLS CUI [1,1]
C0750492
UMLS CUI [1,2]
C0018823
UMLS CUI [1,3]
C0016884
UMLS CUI [2,1]
C0750492
UMLS CUI [2,2]
C0181598
UMLS CUI [2,3]
C0016884
patients on long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness or heart failure
Description

long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness or heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0420257
UMLS CUI [1,2]
C0304509
UMLS CUI [1,3]
C0574032
UMLS CUI [2,1]
C0205103
UMLS CUI [2,2]
C0304509
UMLS CUI [2,3]
C0574032
UMLS CUI [3,1]
C0023671
UMLS CUI [3,2]
C0392756
UMLS CUI [3,3]
C0009488
UMLS CUI [4,1]
C0023671
UMLS CUI [4,2]
C0392756
UMLS CUI [4,3]
C0018801
patients who report severe sleepiness or who consider themselves at risk while driving
Description

reporting severe sleepiness or considering themselves at risk while driving

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0004379
patients who fail the secondary screening procedure. secondary screening procedure involves the patient being asked to wear the device and experience the pressure delivery for at least 30 minutes while relaxed.
Description

failing the secondary screening procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205436
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C0231175
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Similar models

Eligibility Sleep Apnea Syndromes NCT02505867

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
heart failure and acute heart failure syndrome defined by: chief complaint of dyspnea or fatigue; elevated left ventricular pressure
Item
admission diagnosis of heart failure and acute heart failure syndrome as defined by the following: a chief complaint of dyspnea or fatigue; elevated left ventricular pressure. elevated left ventricular pressure is indicated by at least one of the following: signs of volume overload pedal edema, crackles, consistent chest x-ray, increased measurement of left ventricular end-diastolic diameter or volume, or elevated bnp level.
boolean
C0018801 (UMLS CUI [1])
C0264714 (UMLS CUI [2])
C0277786 (UMLS CUI [3,1])
C0013404 (UMLS CUI [3,2])
C0277786 (UMLS CUI [4,1])
C0015672 (UMLS CUI [4,2])
C3163633 (UMLS CUI [5,1])
C0456189 (UMLS CUI [5,2])
previously unrecognized and/or untreated SDB diagnosed or confirmed by polysomnography during hospitalization with ahfs
Item
previously unrecognized or recognized but untreated sleep disordered breathing diagnosed or confirmed on attended inpatient sleep study during the index hospitalization with ahfs. sdb is defined as one of the following syndromes: 1. ahi>15 with more than 50% apneas being central (csa); or 2. ahi>30 events with more than 50% of the events being obstructive (severe osa) in patients with lvef <30%
boolean
C0205156 (UMLS CUI [1,1])
C4288068 (UMLS CUI [1,2])
C0037315 (UMLS CUI [1,3])
C0162701 (UMLS CUI [1,4])
C0019993 (UMLS CUI [1,5])
C0264714 (UMLS CUI [1,6])
C0205156 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0037315 (UMLS CUI [2,3])
C0162701 (UMLS CUI [2,4])
C0019993 (UMLS CUI [2,5])
C0264714 (UMLS CUI [2,6])
expected length of stay
Item
projected length of stay >2 days on admission day to ensure uniformity of the underlying severity of the ahfs and to enable the introduction of the asv device and education
boolean
C1517001 (UMLS CUI [1,1])
C0023303 (UMLS CUI [1,2])
recent left ventricular ejection fraction
Item
lvef <45% within 1 year of admission. an echocardiogram may be performed to confirm the lvef during the hospitalization to determine eligibility.
boolean
C0332185 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
ongoing targeted treatment for heart failure during current hospitalization including: iv diuretics, iv infusion of inotropes or vasodilators, or planned revascularization, or device therapy
Item
ongoing targeted treatment for heart failure during the current hospitalization including at least one of the following: iv diuretics, iv infusion of inotropes or vasodilators, or planned revascularization, or device therapy.
boolean
C0549178 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0019993 (UMLS CUI [1,5])
C0012798 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0304509 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C1522726 (UMLS CUI [4,1])
C0042402 (UMLS CUI [4,2])
C1301732 (UMLS CUI [5,1])
C0581603 (UMLS CUI [5,2])
C1504335 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
supplemental oxygen as prior therapy for indication other than sdb or heart failure (chronic respiratory insufficiency)
Item
patients who were on supplemental oxygen for an indication other than sdb or heart failure prior to admission. these are patients who have chronic respiratory insufficiency.
boolean
C1514463 (UMLS CUI [1,1])
C4534306 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0037315 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C3146298 (UMLS CUI [3,2])
C0018801 (UMLS CUI [3,3])
C1998122 (UMLS CUI [4])
on treatment targeting csa or osa and already provided and rejected positive airway pressure therapy due to intolerance of the pressure or claustrophobia
Item
patients on treatment targeting csa or osa (asv, oxygen, or cpap); and patients who already provided and rejected positive airway pressure therapy due to intolerance of the pressure or the claustrophobia.
boolean
C0087111 (UMLS CUI [1,1])
C0520680 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0520679 (UMLS CUI [2,2])
C0199451 (UMLS CUI [3,1])
C1548437 (UMLS CUI [3,2])
C1704410 (UMLS CUI [3,3])
C0205160 (UMLS CUI [3,4])
C0199451 (UMLS CUI [4,1])
C1548437 (UMLS CUI [4,2])
C0008909 (UMLS CUI [4,3])
cardiogenic shock and hemodynamic instability with map less than 55 mmhg off vasopressors, or concurrently on vasopressor treatment, left ventricular assist devices, or intra-aortic balloon pump. inotropic agents will not constitute an exclusion criterion
Item
cardiogenic shock and hemodynamic instability with map less than 55 mmhg off vasopressors, or concurrently on vasopressor treatment, left ventricular assist devices, or intra-aortic balloon pump. inotropic agents will not constitute an exclusion criterion. patients will be eligible once more stable off vasopressors.
boolean
C0036980 (UMLS CUI [1,1])
C0428886 (UMLS CUI [1,2])
C1518544 (UMLS CUI [1,3])
C0042397 (UMLS CUI [1,4])
C0948268 (UMLS CUI [2,1])
C0428886 (UMLS CUI [2,2])
C1518544 (UMLS CUI [2,3])
C0042397 (UMLS CUI [2,4])
C0036980 (UMLS CUI [3,1])
C0428886 (UMLS CUI [3,2])
C0042397 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C0304509 (UMLS CUI [4,2])
C0036980 (UMLS CUI [5,1])
C0428886 (UMLS CUI [5,2])
C0181598 (UMLS CUI [5,3])
C0036980 (UMLS CUI [6,1])
C0428886 (UMLS CUI [6,2])
C0702122 (UMLS CUI [6,3])
C0948268 (UMLS CUI [7,1])
C0428886 (UMLS CUI [7,2])
C0042397 (UMLS CUI [7,3])
C0332300 (UMLS CUI [8,1])
C0304509 (UMLS CUI [8,2])
C0948268 (UMLS CUI [9,1])
C0428886 (UMLS CUI [9,2])
C0181598 (UMLS CUI [9,3])
C0948268 (UMLS CUI [10,1])
C0428886 (UMLS CUI [10,2])
C0021860 (UMLS CUI [10,3])
acute respiratory failure or insufficiency defined by pao2/fio2 ratio or fio2 requirement
Item
acute respiratory failure or insufficiency defined by (pao2/fio2) ratio less than 250, or fio2 requirement more than 40%. patients are eligible to participate once their fio2 requirement is below 30%.
boolean
C0205178 (UMLS CUI [1,1])
C1145670 (UMLS CUI [1,2])
C0205178 (UMLS CUI [2,1])
C0035229 (UMLS CUI [2,2])
C4087239 (UMLS CUI [3])
C0428167 (UMLS CUI [4])
overt neurological deficit or having arrived from or being expected to be dicharged to a long-term care facility and having poor functional outcome precluding ability for independent use of asv device
Item
overt neurological deficit or patients who arrived from a long-term care facility or expected to be discharged to one; and patients who have very poor functional outcome precluding ability to use the asv device independently
boolean
C0521654 (UMLS CUI [1])
C2982691 (UMLS CUI [2,1])
C1708733 (UMLS CUI [2,2])
C1517001 (UMLS CUI [3,1])
C0030685 (UMLS CUI [3,2])
C1708733 (UMLS CUI [3,3])
C2700379 (UMLS CUI [4,1])
C1547647 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1299583 (UMLS CUI [4,4])
C4285752 (UMLS CUI [4,5])
C0699733 (UMLS CUI [4,6])
renal failure requiring renal replacement therapy. not excluded for undergoing ultra-filtration for volume removal
Item
renal failure requiring renal replacement therapy; patients will not be excluded if they were undergoing ultra-filtration for volume removal.
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0206074 (UMLS CUI [1,3])
C0332300 (UMLS CUI [2,1])
C0041612 (UMLS CUI [2,2])
C0449468 (UMLS CUI [2,3])
C1883720 (UMLS CUI [2,4])
moderate to severe chronic obstructive lung disease (fev1/fvc < 55%)
Item
moderate to severe chronic obstructive lung disease (fev1/fvc < 55%).
boolean
C1299393 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
C0429745 (UMLS CUI [2])
likely to receive heart transplant or left ventricular assist device (lvad) in the subsequent year
Item
patients who are likely to receive heart transplant or left ventricular assist device (lvad) in the subsequent year. these are patients who have high standing on the transplant list during the index hospitalization or have a cardiothoracic evaluation for implantation of lvad.
boolean
C0750492 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0016884 (UMLS CUI [1,3])
C0750492 (UMLS CUI [2,1])
C0181598 (UMLS CUI [2,2])
C0016884 (UMLS CUI [2,3])
long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness or heart failure
Item
patients on long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness or heart failure
boolean
C0420257 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
C0205103 (UMLS CUI [2,1])
C0304509 (UMLS CUI [2,2])
C0574032 (UMLS CUI [2,3])
C0023671 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
C0009488 (UMLS CUI [3,3])
C0023671 (UMLS CUI [4,1])
C0392756 (UMLS CUI [4,2])
C0018801 (UMLS CUI [4,3])
reporting severe sleepiness or considering themselves at risk while driving
Item
patients who report severe sleepiness or who consider themselves at risk while driving
boolean
C0013144 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0035647 (UMLS CUI [2,1])
C0004379 (UMLS CUI [2,2])
failing the secondary screening procedure
Item
patients who fail the secondary screening procedure. secondary screening procedure involves the patient being asked to wear the device and experience the pressure delivery for at least 30 minutes while relaxed.
boolean
C0205436 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
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