ID

40870

Description

Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing; ODM derived from: https://clinicaltrials.gov/show/NCT01657188

Link

https://clinicaltrials.gov/show/NCT01657188

Keywords

Versions (1)
  1. 5/28/20 5/28/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 28, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT01657188

English

Eligibility Heart Failure, Congestive NCT01657188

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stable heart failure nyha ≥ ii
Description

Heart failure Stable New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C1275491
ef ≤ 45%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
without sleep-disordered breathing (apnea-hypopnea-index <5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy
Description

Sleep Apnea Syndrome Absent | Apnea-hypopnea index | Central Sleep Apnea Moderate | Central Sleep Apnea Severe | Adaptive servo-ventilation | Adaptive servo-ventilation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C2111846
UMLS CUI [3,1]
C0520680
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C0520680
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C4285752
UMLS CUI [6,1]
C4285752
UMLS CUI [6,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiac resynchronization or pacemaker implantation within the last 6 months
Description

Cardiac Resynchronization Therapy | Implantation of cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C0189842
significant copd with an forced expiratory one-second capacity relative to vital capacity (fev1/vc)< 70% (gold iii)
Description

Chronic Obstructive Airway Disease Stage | FEV1/VC ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C1306673
UMLS CUI [2]
C0429744
respiratory insufficiency requiring long-term oxygen therapy
Description

Respiratory Insufficiency | Long-term oxygen therapy Required

Data type

boolean

Alias
UMLS CUI [1]
C0035229
UMLS CUI [2,1]
C0418996
UMLS CUI [2,2]
C1514873
daytime hypercapnia at rest (pco2 > 45 mmhg)
Description

Hypercapnia Daytime At rest | PCO2

Data type

boolean

Alias
UMLS CUI [1,1]
C0020440
UMLS CUI [1,2]
C0332169
UMLS CUI [1,3]
C0443144
UMLS CUI [2]
C0201931
current ventilation therapy
Description

Ventilation (treatment)

Data type

boolean

Alias
UMLS CUI [1]
C0554804
cardiac surgery, pci, myocardial infarction, unstable angina, tia or stroke within 12 weeks prior to randomization
Description

Cardiac Surgery procedures | Percutaneous Coronary Intervention | Myocardial Infarction | Angina, Unstable | Transient Ischemic Attack | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0007787
UMLS CUI [6]
C0038454
acute myocarditis within 6 months prior to randomization
Description

Myocarditis

Data type

boolean

Alias
UMLS CUI [1]
C0027059
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Heart Failure, Congestive NCT01657188

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Stable New York Heart Association Classification
Item
stable heart failure nyha ≥ ii
boolean
C0018801 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Cardiac ejection fraction
Item
ef ≤ 45%
boolean
C0232174 (UMLS CUI [1])
Sleep Apnea Syndrome Absent | Apnea-hypopnea index | Central Sleep Apnea Moderate | Central Sleep Apnea Severe | Adaptive servo-ventilation | Adaptive servo-ventilation Absent
Item
without sleep-disordered breathing (apnea-hypopnea-index <5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy
boolean
C0037315 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2111846 (UMLS CUI [2])
C0520680 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0520680 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C4285752 (UMLS CUI [5])
C4285752 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Cardiac Resynchronization Therapy | Implantation of cardiac pacemaker
Item
cardiac resynchronization or pacemaker implantation within the last 6 months
boolean
C1167956 (UMLS CUI [1])
C0189842 (UMLS CUI [2])
Chronic Obstructive Airway Disease Stage | FEV1/VC ratio
Item
significant copd with an forced expiratory one-second capacity relative to vital capacity (fev1/vc)< 70% (gold iii)
boolean
C0024117 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0429744 (UMLS CUI [2])
Respiratory Insufficiency | Long-term oxygen therapy Required
Item
respiratory insufficiency requiring long-term oxygen therapy
boolean
C0035229 (UMLS CUI [1])
C0418996 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Hypercapnia Daytime At rest | PCO2
Item
daytime hypercapnia at rest (pco2 > 45 mmhg)
boolean
C0020440 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,3])
C0201931 (UMLS CUI [2])
Ventilation (treatment)
Item
current ventilation therapy
boolean
C0554804 (UMLS CUI [1])
Cardiac Surgery procedures | Percutaneous Coronary Intervention | Myocardial Infarction | Angina, Unstable | Transient Ischemic Attack | Cerebrovascular accident
Item
cardiac surgery, pci, myocardial infarction, unstable angina, tia or stroke within 12 weeks prior to randomization
boolean
C0018821 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
Myocarditis
Item
acute myocarditis within 6 months prior to randomization
boolean
C0027059 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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