ID

42357

Beskrivning

Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01128816

Länk

https://clinicaltrials.gov/show/NCT01128816

Nyckelord

Versioner (1)
  1. 22/06/2021 22/06/2021 -
Rättsinnehavare

Toronto Rehabilitation Institute Canadian Institutes of Health Research (CIHR) Philips Respironics

Uppladdad den

22 de junho de 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Sleep Apnea NCT01128816

Engelsk

Eligibility Sleep Apnea NCT01128816

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
american heart association stage b-d heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
Beskrivning

Heart failure due to ischemic, idiopathic or hypertensive causes | New York Heart Association | Duration Minumum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [1,3]
C0475224
UMLS CUI [1,4]
C0449238
UMLS CUI [1,5]
C1524031
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [2,3]
C0332240
UMLS CUI [2,4]
C0449238
UMLS CUI [2,5]
C1524031
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0020538
UMLS CUI [3,5]
C0449238
UMLS CUI [3,6]
C1524031
left ventricular ejection fraction ≤ 45 %
Beskrivning

Left ventricular ejection fraction decreased

Datatyp

boolean

Alias
UMLS CUI [1]
C0743400
optimal medical therapy for heart failure
Beskrivning

Optimal medical therapy for heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2698651
no change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
Beskrivning

No change recent of cardiac medication | Betablockers minimal duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0580105
UMLS CUI [1,3]
C0018787
UMLS CUI [1,4]
C0332185
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C1524031
sleep apnea with an ahi ≥ 15. subjects with obstructive sleep apnea must also have an epworth sleepiness scale score of ≤ 10 and no or mild daytime sleepiness
Beskrivning

Sleep apnea with AHI ≥ 15 | Obstructive sleep apnea with an epworth sleepiness scale score of ≤ 10 and no or mild daytime sleepiness

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C4083070
UMLS CUI [2,1]
C0520679
UMLS CUI [2,2]
C3541276
UMLS CUI [2,3]
C0332169
UMLS CUI [2,4]
C0013144
UMLS CUI [2,5]
C2945599
UMLS CUI [3,1]
C0520679
UMLS CUI [3,2]
C3541276
UMLS CUI [3,3]
C0332169
UMLS CUI [3,4]
C0013144
UMLS CUI [3,5]
C0332197
written informed consent
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
heart failure due to primary valvular heart disease
Beskrivning

Heart failure due to primary valvular heart disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0018824
UMLS CUI [1,4]
C0205225
presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
Beskrivning

Moderate to severe mitral insuficiency due to intrinsic mitral valve disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C1299393
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0439674
UMLS CUI [1,5]
C0026265
hypertrophic obstructive or restrictive or post partum cardiomyopathy
Beskrivning

Hypertrophic obstructive cardiomyopathy | Restrictive cardiomyopathy | Post partum cardiomyopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0007196
UMLS CUI [3,1]
C0687676
UMLS CUI [3,2]
C1148523
UMLS CUI [3,3]
C0878544
exercise capacity limited by class iv angina pectoris
Beskrivning

Exercise capacity limited by class iv angina pectoris

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0002962
UMLS CUI [1,5]
C0008902
acute mi, cardiac surgery, pci, aicd, or crt within 3 months of randomization
Beskrivning

Recent acute mi | Cardiac surgery | pci | aicd | crt

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0972395
UMLS CUI [4,2]
C0332185
UMLS CUI [5,1]
C1167956
UMLS CUI [5,2]
C0332185
active myocarditis
Beskrivning

Myocarditis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027059
planned aicd or crt
Beskrivning

Planned aicd or crt

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0972395
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C1301732
presence of a left-ventricular assist device
Beskrivning

Left-ventricular assist device

Datatyp

boolean

Alias
UMLS CUI [1]
C0181598
transplanted heart or expected to receive a transplanted heart within the next 6 months
Beskrivning

Transplanted heart | Expected to receive a transplanted heart

Datatyp

boolean

Alias
UMLS CUI [1]
C2029943
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C1517001
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
current use of asv or cpap or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications)
Beskrivning

Current use of ASV | Current use of CPAP | Recent investigational therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C4285752
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0199451
UMLS CUI [3,1]
C0949266
UMLS CUI [3,2]
C0332185
a clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study
Beskrivning

A clinical history that would interfere with the objectives of this stady or that would in the investigator's opinion preclude safe conclusion of the study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0018017
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0035173
UMLS CUI [2,4]
C0871010
UMLS CUI [2,5]
C0332197
UMLS CUI [2,6]
C0036043
any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance)
Beskrivning

Other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0205476
UMLS CUI [1,5]
C0348080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0750558
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0748872
UMLS CUI [2,5]
C0348080
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0750558
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C1517526
UMLS CUI [3,5]
C0348080
any contraindication to asv therapy as detailed in the device provider manual
Beskrivning

Contraindication to asv therapy as detailed in the device provider manual

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4285752
UMLS CUI [1,3]
C0025080
UMLS CUI [1,4]
C1442085
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Similar models

Eligibility Sleep Apnea NCT01128816

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure due to ischemic, idiopathic or hypertensive causes | New York Heart Association | Duration Minumum
Item
american heart association stage b-d heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0475224 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C1524031 (UMLS CUI [1,5])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0332240 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1524031 (UMLS CUI [2,5])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0020538 (UMLS CUI [3,4])
C0449238 (UMLS CUI [3,5])
C1524031 (UMLS CUI [3,6])
Left ventricular ejection fraction decreased
Item
left ventricular ejection fraction ≤ 45 %
boolean
C0743400 (UMLS CUI [1])
Optimal medical therapy for heart failure
Item
optimal medical therapy for heart failure
boolean
C0018801 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
No change recent of cardiac medication | Betablockers minimal duration
Item
no change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
boolean
C0332197 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C0304516 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
Sleep apnea with AHI ≥ 15 | Obstructive sleep apnea with an epworth sleepiness scale score of ≤ 10 and no or mild daytime sleepiness
Item
sleep apnea with an ahi ≥ 15. subjects with obstructive sleep apnea must also have an epworth sleepiness scale score of ≤ 10 and no or mild daytime sleepiness
boolean
C0037315 (UMLS CUI [1,1])
C4083070 (UMLS CUI [1,2])
C0520679 (UMLS CUI [2,1])
C3541276 (UMLS CUI [2,2])
C0332169 (UMLS CUI [2,3])
C0013144 (UMLS CUI [2,4])
C2945599 (UMLS CUI [2,5])
C0520679 (UMLS CUI [3,1])
C3541276 (UMLS CUI [3,2])
C0332169 (UMLS CUI [3,3])
C0013144 (UMLS CUI [3,4])
C0332197 (UMLS CUI [3,5])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart failure due to primary valvular heart disease
Item
heart failure due to primary valvular heart disease
boolean
C0018801 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0018824 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
Moderate to severe mitral insuficiency due to intrinsic mitral valve disease
Item
presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
boolean
C0026266 (UMLS CUI [1,1])
C1299393 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0439674 (UMLS CUI [1,4])
C0026265 (UMLS CUI [1,5])
Hypertrophic obstructive cardiomyopathy | Restrictive cardiomyopathy | Post partum cardiomyopathy
Item
hypertrophic obstructive or restrictive or post partum cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
C0007196 (UMLS CUI [2])
C0687676 (UMLS CUI [3,1])
C1148523 (UMLS CUI [3,2])
C0878544 (UMLS CUI [3,3])
Exercise capacity limited by class iv angina pectoris
Item
exercise capacity limited by class iv angina pectoris
boolean
C0015259 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0002962 (UMLS CUI [1,4])
C0008902 (UMLS CUI [1,5])
Recent acute mi | Cardiac surgery | pci | aicd | crt
Item
acute mi, cardiac surgery, pci, aicd, or crt within 3 months of randomization
boolean
C0155626 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0018821 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1532338 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0972395 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C1167956 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
Myocarditis
Item
active myocarditis
boolean
C0027059 (UMLS CUI [1])
Planned aicd or crt
Item
planned aicd or crt
boolean
C0972395 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1532338 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Left-ventricular assist device
Item
presence of a left-ventricular assist device
boolean
C0181598 (UMLS CUI [1])
Transplanted heart | Expected to receive a transplanted heart
Item
transplanted heart or expected to receive a transplanted heart within the next 6 months
boolean
C2029943 (UMLS CUI [1])
C0018823 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Current use of ASV | Current use of CPAP | Recent investigational therapy
Item
current use of asv or cpap or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications)
boolean
C0521116 (UMLS CUI [1,1])
C4285752 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0199451 (UMLS CUI [2,2])
C0949266 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
A clinical history that would interfere with the objectives of this stady or that would in the investigator's opinion preclude safe conclusion of the study
Item
a clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study
boolean
C0262926 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0018017 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0262926 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0035173 (UMLS CUI [2,3])
C0871010 (UMLS CUI [2,4])
C0332197 (UMLS CUI [2,5])
C0036043 (UMLS CUI [2,6])
Other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures
Item
any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance)
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0205476 (UMLS CUI [1,4])
C0348080 (UMLS CUI [1,5])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0748872 (UMLS CUI [2,4])
C0348080 (UMLS CUI [2,5])
C0525058 (UMLS CUI [3,1])
C0750558 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C1517526 (UMLS CUI [3,4])
C0348080 (UMLS CUI [3,5])
Contraindication to asv therapy as detailed in the device provider manual
Item
any contraindication to asv therapy as detailed in the device provider manual
boolean
C1301624 (UMLS CUI [1,1])
C4285752 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C1442085 (UMLS CUI [1,4])
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