0 Beoordelingen
ID

42357

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01128816

Trefwoorden

Versies (1)
  1. 22-06-21 22-06-21 -
Houder van rechten

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

Geüploaded op

22 juni 2021

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Sleep Apnea NCT01128816

    Engels

    Eligibility Sleep Apnea NCT01128816

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    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
    Beschrijving

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

    Datatype

    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 %
    Beschrijving

    Left ventricular ejection fraction decreased

    Datatype

    boolean

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

    Optimal medical therapy for heart failure

    Datatype

    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
    Beschrijving

    No change recent of cardiac medication | Betablockers minimal duration

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

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

    Heart failure due to primary valvular heart disease

    Datatype

    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
    Beschrijving

    Moderate to severe mitral insuficiency due to intrinsic mitral valve disease

    Datatype

    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
    Beschrijving

    Hypertrophic obstructive cardiomyopathy | Restrictive cardiomyopathy | Post partum cardiomyopathy

    Datatype

    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
    Beschrijving

    Exercise capacity limited by class iv angina pectoris

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Myocarditis

    Datatype

    boolean

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

    Planned aicd or crt

    Datatype

    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
    Beschrijving

    Left-ventricular assist device

    Datatype

    boolean

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

    Transplanted heart | Expected to receive a transplanted heart

    Datatype

    boolean

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

    Pregnancy

    Datatype

    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)
    Beschrijving

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

    Datatype

    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
    Beschrijving

    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

    Datatype

    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)
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Contraindication to asv therapy as detailed in the device provider manual

    Datatype

    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 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

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