ID

4988

Description

ODM derived from http://clinicaltrials.gov/show/NCT00733343

Link

http://clinicaltrials.gov/show/NCT00733343

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
Uploaded on

April 16, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00733343 Heart Failure

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 22 Years
Description

age at least 22 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
Description

Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)

Data type

boolean

Alias
UMLS CUI 2011AA
C0264716
SNOMED CT 2011_0131
48447003
MedDRA 14.1
10008908
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0220845
Left ventricular systolic dysfunction (LVEF <= 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
Description

Left ventricular systolic dysfunction (LVEF <= 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation

Data type

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
C0011923
SNOMED CT 2011_0131
363679005
UMLS CUI 2011AA
C0013516
SNOMED CT 2011_0131
40701008
MedDRA 14.1
10014116
ICD-9-CM Version 2011
88.72
UMLS CUI 2011AA
C0034604
UMLS CUI 2011AA
C0412219
SNOMED CT 2011_0131
265484009
MedDRA 14.1
10024122
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
Description

NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months

Data type

boolean

Alias
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C1319794
SNOMED CT 2011_0131
421704003
MedDRA 14.1
10064080
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
No hospitalisation for heart failure for at least 4 weeks prior to inclusion
Description

No hospitalisation for heart failure for at least 4 weeks prior to inclusion

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE inhibitors/ ARB antagonists the reasons must be documented
Description

Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE inhibitors/ ARB antagonists the reasons must be documented

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0220845
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0001645
SNOMED CT 2011_0131
33252009
LOINC Version 232
MTHU003324
UMLS CUI 2011AA
C0003015
SNOMED CT 2011_0131
372733002
UMLS CUI 2011AA
C0521942
SNOMED CT 2011_0131
372913009
SDB (AHI > 15/h with >= 50% central events and a central AHI >= 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
Description

SDB (AHI > 15/h with >= 50% central events and a central AHI >= 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula

Data type

boolean

Alias
UMLS CUI 2011AA
C0037315
SNOMED CT 2011_0131
73430006
MedDRA 14.1
10040979
ICD-10-CM Version 2010
G47.30
ICD-9-CM Version 2011
780.57
CTCAE 1105E
E13566
UMLS CUI 2011AA
C0003578
SNOMED CT 2011_0131
1023001
MedDRA 14.1
10002974
ICD-10-CM Version 2010
R06.81
ICD-9-CM Version 2011
786.03
CTCAE 1105E
E13306
UMLS CUI 2011AA
C0235546
SNOMED CT 2011_0131
386614005
MedDRA 14.1
10021079
UMLS CUI 2011AA
C0918012
UMLS CUI 2011AA
C0597266
UMLS CUI 2011AA
C0162701
SNOMED CT 2011_0131
60554003
MedDRA 14.1
10053319
ICD-9-CM Version 2011
89.17
UMLS CUI 2011AA
C0439810
SNOMED CT 2011_0131
255619001
UMLS CUI 2011AA
C0034869
UMLS CUI 2011AA
C0040223
SNOMED CT 2011_0131
410670007
LOINC Version 232
MTHU009151
UMLS CUI 2011AA
C0521140
SNOMED CT 2011_0131
46713006
HL7 V3 2006_05
_NasalRoute
UMLS CUI 2011AA
C0520453
SNOMED CT 2011_0131
12150006
LOINC Version 232
MTHU022488
Patients for whom the use of AutoSet CS2/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
Description

Patients for whom the use of AutoSet CS2/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0020649
SNOMED CT 2011_0131
45007003
MedDRA 14.1
10003146
ICD-10-CM Version 2010
I95
ICD-9-CM Version 2011
458
UMLS CUI 2011AA
C0442123
SNOMED CT 2011_0131
261101003
LOINC Version 232
MTHU024432
UMLS CUI 2011AA
C2700258
UMLS CUI 2011AA
C0333668
SNOMED CT 2011_0131
69251000
UMLS CUI 2011AA
C0032326
SNOMED CT 2011_0131
36118008
MedDRA 14.1
10035759
ICD-10-CM Version 2010
J93
ICD-9-CM Version 2011
512
CTCAE 1105E
E13508
UMLS CUI 2011AA
C0025062
SNOMED CT 2011_0131
16838000
MedDRA 14.1
10050184
ICD-10-CM Version 2010
J98.2
Patient is able to fully understand study information and signed informed consent
Description

Patient is able to fully understand study information and signed informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Significant COPD with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
Description

Significant COPD with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0024117
SNOMED CT 2011_0131
13645005
MedDRA 14.1
10009033
ICD-10-CM Version 2010
J44.9
ICD-9-CM Version 2011
496
UMLS CUI 2011AA
CL414841
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Oxygen saturation at rest during the day <= 90% at inclusion
Description

Oxygen saturation at rest during the day <= 90% at inclusion

Data type

boolean

Alias
UMLS CUI 2011AA
C0523807
SNOMED CT 2011_0131
264598005
MedDRA 14.1
10033316
UMLS CUI 2011AA
C0443144
SNOMED CT 2011_0131
263678003
UMLS CUI 2011AA
C0585022
SNOMED CT 2011_0131
307143006
Current use of Positive Airway Pressure (PAP) - therapy
Description

Current use of Positive Airway Pressure (PAP) - therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0428719
SNOMED CT 2011_0131
250852008
LOINC Version 232
MTHU008125
UMLS CUI 2011AA
C0039798
Life expectancy < 1 year for diseases unrelated to chronic HF
Description

Life expectancy < 1 year for diseases unrelated to chronic HF

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
CL414700
UMLS CUI 2011AA
C0264716
SNOMED CT 2011_0131
48447003
MedDRA 14.1
10008908
Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
Description

Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation

Data type

boolean

Alias
UMLS CUI 2011AA
C0524727
SNOMED CT 2011_0131
408466002
UMLS CUI 2011AA
C0522523
SNOMED CT 2011_0131
103388001
UMLS CUI 2011AA
C0018787
SNOMED CT 2011_0131
80891009
LOINC Version 232
MTHU001067
UMLS CUI 2011AA
C1948041
SNOMED CT 2011_0131
71388002
MedDRA 14.1
10042613
LOINC Version 232
MTHU006237
ICD-9-CM Version 2011
00-99.99
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
CRT-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
Description

CRT-implantation or ICD-implantation scheduled or within 6 months prior to randomisation

Data type

boolean

Alias
UMLS CUI 2011AA
C1167956
MedDRA 14.1
10059862
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
Description

Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation

Data type

boolean

Alias
UMLS CUI 2011AA
C0007787
SNOMED CT 2011_0131
266257000
MedDRA 14.1
10044390
LOINC Version 232
MTHU020810
ICD-10-CM Version 2010
G45.9
ICD-9-CM Version 2011
435.9
CTCAE 1105E
E12834
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
Description

Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial

Data type

boolean

Alias
UMLS CUI 2011AA
C0019010
UMLS CUI 2011AA
C0018824
SNOMED CT 2011_0131
368009
MedDRA 14.1
10061406
UMLS CUI 2011AA
C0028778
SNOMED CT 2011_0131
26036001
MedDRA 14.1
10061876
UMLS CUI 2011AA
C1301411
SNOMED CT 2011_0131
397417004
UMLS CUI 2011AA
C1399222
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
C0038895
Acute myocarditis/pericarditis within 6 months prior to randomisation
Description

Acute myocarditis/pericarditis within 6 months prior to randomisation

Data type

boolean

Alias
UMLS CUI 2011AA
C0155686
SNOMED CT 2011_0131
46701001
MedDRA 14.1
10000932
ICD-10-CM Version 2010
I40.9
ICD-9-CM Version 2011
422.90
UMLS CUI 2011AA
C0155679
SNOMED CT 2011_0131
15555002
MedDRA 14.1
10000996
ICD-10-CM Version 2010
I30
ICD-9-CM Version 2011
420
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
Description

Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C0035258
SNOMED CT 2011_0131
32914008
MedDRA 14.1
10058920
ICD-10-CM Version 2010
G25.81
ICD-9-CM Version 2011
333.94
Pregnancy, Gestation
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 22 Years
Item
age at least 22 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
Item
Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
boolean
C0264716 (UMLS CUI 2011AA)
48447003 (SNOMED CT 2011_0131)
10008908 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0680240 (UMLS CUI 2011AA)
C0220845 (UMLS CUI 2011AA)
Left ventricular systolic dysfunction (LVEF <= 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
Item
Left ventricular systolic dysfunction (LVEF <= 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C0011923 (UMLS CUI 2011AA)
363679005 (SNOMED CT 2011_0131)
C0013516 (UMLS CUI 2011AA)
40701008 (SNOMED CT 2011_0131)
10014116 (MedDRA 14.1)
88.72 (ICD-9-CM Version 2011)
C0034604 (UMLS CUI 2011AA)
C0412219 (UMLS CUI 2011AA)
265484009 (SNOMED CT 2011_0131)
10024122 (MedDRA 14.1)
C1522601 (UMLS CUI 2011AA)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
Item
NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 24 months
boolean
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
No hospitalisation for heart failure for at least 4 weeks prior to inclusion
Item
No hospitalisation for heart failure for at least 4 weeks prior to inclusion
boolean
C1518422 (UMLS CUI 2011AA)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE inhibitors/ ARB antagonists the reasons must be documented
Item
Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE inhibitors/ ARB antagonists the reasons must be documented
boolean
C0039798 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0220845 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0001645 (UMLS CUI 2011AA)
33252009 (SNOMED CT 2011_0131)
MTHU003324 (LOINC Version 232)
C0003015 (UMLS CUI 2011AA)
372733002 (SNOMED CT 2011_0131)
C0521942 (UMLS CUI 2011AA)
372913009 (SNOMED CT 2011_0131)
SDB (AHI > 15/h with >= 50% central events and a central AHI >= 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
Item
SDB (AHI > 15/h with >= 50% central events and a central AHI >= 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
boolean
C0037315 (UMLS CUI 2011AA)
73430006 (SNOMED CT 2011_0131)
10040979 (MedDRA 14.1)
G47.30 (ICD-10-CM Version 2010)
780.57 (ICD-9-CM Version 2011)
E13566 (CTCAE 1105E)
C0003578 (UMLS CUI 2011AA)
1023001 (SNOMED CT 2011_0131)
10002974 (MedDRA 14.1)
R06.81 (ICD-10-CM Version 2010)
786.03 (ICD-9-CM Version 2011)
E13306 (CTCAE 1105E)
C0235546 (UMLS CUI 2011AA)
386614005 (SNOMED CT 2011_0131)
10021079 (MedDRA 14.1)
C0918012 (UMLS CUI 2011AA)
C0597266 (UMLS CUI 2011AA)
C0162701 (UMLS CUI 2011AA)
60554003 (SNOMED CT 2011_0131)
10053319 (MedDRA 14.1)
89.17 (ICD-9-CM Version 2011)
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
C0034869 (UMLS CUI 2011AA)
C0040223 (UMLS CUI 2011AA)
410670007 (SNOMED CT 2011_0131)
MTHU009151 (LOINC Version 232)
C0521140 (UMLS CUI 2011AA)
46713006 (SNOMED CT 2011_0131)
_NasalRoute (HL7 V3 2006_05)
C0520453 (UMLS CUI 2011AA)
12150006 (SNOMED CT 2011_0131)
MTHU022488 (LOINC Version 232)
Patients for whom the use of AutoSet CS2/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
Item
Patients for whom the use of AutoSet CS2/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C2346570 (UMLS CUI 2011AA)
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0020649 (UMLS CUI 2011AA)
45007003 (SNOMED CT 2011_0131)
10003146 (MedDRA 14.1)
I95 (ICD-10-CM Version 2010)
458 (ICD-9-CM Version 2011)
C0442123 (UMLS CUI 2011AA)
261101003 (SNOMED CT 2011_0131)
MTHU024432 (LOINC Version 232)
C2700258 (UMLS CUI 2011AA)
C0333668 (UMLS CUI 2011AA)
69251000 (SNOMED CT 2011_0131)
C0032326 (UMLS CUI 2011AA)
36118008 (SNOMED CT 2011_0131)
10035759 (MedDRA 14.1)
J93 (ICD-10-CM Version 2010)
512 (ICD-9-CM Version 2011)
E13508 (CTCAE 1105E)
C0025062 (UMLS CUI 2011AA)
16838000 (SNOMED CT 2011_0131)
10050184 (MedDRA 14.1)
J98.2 (ICD-10-CM Version 2010)
Patient is able to fully understand study information and signed informed consent
Item
Patient is able to fully understand study information and signed informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Significant COPD with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
Item
Significant COPD with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
CL414841 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Oxygen saturation at rest during the day <= 90% at inclusion
Item
Oxygen saturation at rest during the day <= 90% at inclusion
boolean
C0523807 (UMLS CUI 2011AA)
264598005 (SNOMED CT 2011_0131)
10033316 (MedDRA 14.1)
C0443144 (UMLS CUI 2011AA)
263678003 (SNOMED CT 2011_0131)
C0585022 (UMLS CUI 2011AA)
307143006 (SNOMED CT 2011_0131)
Current use of Positive Airway Pressure (PAP) - therapy
Item
Current use of Positive Airway Pressure (PAP) - therapy
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0428719 (UMLS CUI 2011AA)
250852008 (SNOMED CT 2011_0131)
MTHU008125 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
Life expectancy < 1 year for diseases unrelated to chronic HF
Item
Life expectancy < 1 year for diseases unrelated to chronic HF
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL414700 (UMLS CUI 2011AA)
C0264716 (UMLS CUI 2011AA)
48447003 (SNOMED CT 2011_0131)
10008908 (MedDRA 14.1)
Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
Item
Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
boolean
C0524727 (UMLS CUI 2011AA)
408466002 (SNOMED CT 2011_0131)
C0522523 (UMLS CUI 2011AA)
103388001 (SNOMED CT 2011_0131)
C0018787 (UMLS CUI 2011AA)
80891009 (SNOMED CT 2011_0131)
MTHU001067 (LOINC Version 232)
C1948041 (UMLS CUI 2011AA)
71388002 (SNOMED CT 2011_0131)
10042613 (MedDRA 14.1)
MTHU006237 (LOINC Version 232)
00-99.99 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
CRT-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
Item
CRT-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
boolean
C1167956 (UMLS CUI 2011AA)
10059862 (MedDRA 14.1)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0086960 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
Item
Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
boolean
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
Item
Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
boolean
C0019010 (UMLS CUI 2011AA)
C0018824 (UMLS CUI 2011AA)
368009 (SNOMED CT 2011_0131)
10061406 (MedDRA 14.1)
C0028778 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10061876 (MedDRA 14.1)
C1301411 (UMLS CUI 2011AA)
397417004 (SNOMED CT 2011_0131)
C1399222 (UMLS CUI 2011AA)
C1517001 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
Acute myocarditis/pericarditis within 6 months prior to randomisation
Item
Acute myocarditis/pericarditis within 6 months prior to randomisation
boolean
C0155686 (UMLS CUI 2011AA)
46701001 (SNOMED CT 2011_0131)
10000932 (MedDRA 14.1)
I40.9 (ICD-10-CM Version 2010)
422.90 (ICD-9-CM Version 2011)
C0155679 (UMLS CUI 2011AA)
15555002 (SNOMED CT 2011_0131)
10000996 (MedDRA 14.1)
I30 (ICD-10-CM Version 2010)
420 (ICD-9-CM Version 2011)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
Item
Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
boolean
C1518422 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0035258 (UMLS CUI 2011AA)
32914008 (SNOMED CT 2011_0131)
10058920 (MedDRA 14.1)
G25.81 (ICD-10-CM Version 2010)
333.94 (ICD-9-CM Version 2011)
Pregnancy
Item
Pregnancy, Gestation
boolean
C0549206 (UMLS CUI 2011AA)
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