ID

5092

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT01164592

Link

http://clinicaltrials.gov/show/NCT01164592

Palavras-chave

Versões (2)
  1. 06/12/2013 06/12/2013 - Martin Dugas
  2. 17/04/2014 17/04/2014 - Julian Varghese
Transferido a

17 de abril de 2014

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT01164592 Heart Failure

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrição

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 22 Jahre
Descrição

age at least 22 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
Descrição

Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
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
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
Left ventricular ejection fraction (LVEF) <= 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented < 12 weeks before randomisation
Descrição

Left ventricular ejection fraction (LVEF) <= 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented < 12 weeks before randomisation

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
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
Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr
Descrição

Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
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
C0205099
SNOMED CT 2011_0131
26216008
UMLS CUI 2011AA
C0441471
SNOMED CT 2011_0131
272379006
LOINC Version 232
MTHU019184
Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
Descrição

Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
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
Optimised medical treatment according to the applicable guidelines
Descrição

Optimised medical treatment according to the applicable guidelines

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2698650
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1706839
UMLS CUI 2011AA
C0220845
Able to provide informed consent
Descrição

Able to provide informed consent

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0021430
Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented < 4 weeks before randomization. Flow measurements have to be performed with nasal cannula
Descrição

Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented < 4 weeks before randomization. Flow measurements have to be performed with nasal cannula

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0751762
ICD-10-CM Version 2010
G47.31
ICD-9-CM Version 2011
327.21
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
C0205099
SNOMED CT 2011_0131
26216008
UMLS CUI 2011AA
C0441471
SNOMED CT 2011_0131
272379006
LOINC Version 232
MTHU019184
UMLS CUI 2011AA
C0162701
SNOMED CT 2011_0131
60554003
MedDRA 14.1
10053319
ICD-9-CM Version 2011
89.17
UMLS CUI 2011AA
C0599318
UMLS CUI 2011AA
C0807070
LOINC Version 232
MTHU031476
Ausschlusskriterien
Descrição

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted
Descrição

Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted

Tipo de dados

boolean

Alias
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
Oxygen saturation at rest during the day 90% at the time of inclusion
Descrição

Oxygen saturation at rest during the day 90% at the time of inclusion

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2923814
LOINC Version 232
59417-6
UMLS CUI 2011AA
C0585022
SNOMED CT 2011_0131
307143006
Current use of Positive Airway Pressure (PAP) therapy
Descrição

Current use of Positive Airway Pressure (PAP) therapy

Tipo de dados

boolean

Alias
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 heart failure
Descrição

Life expectancy < 1 year for diseases unrelated to chronic heart failure

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0018821
SNOMED CT 2011_0131
64915003
MedDRA 14.1
10061026
UMLS CUI 2011AA
C1532338
SNOMED CT 2011_0131
415070008
MedDRA 14.1
10065608
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
Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
Descrição

Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C1167956
MedDRA 14.1
10059862
UMLS CUI 2011AA
C0086960
Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
Descrição

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

Tipo de dados

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

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

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL414904
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
C2004489
SNOMED CT 2011_0131
78104003
MedDRA 14.1
10067171
UMLS CUI 2011AA
C1399222
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
C0038895
Acute myocarditis/pericarditis within 6 months prior to randomisation
Descrição

Acute myocarditis/pericarditis within 6 months prior to randomisation

Tipo de dados

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
Untreated or therapy refractory Restless legs Syndrome (RLS)
Descrição

Untreated or therapy refractory Restless legs Syndrome (RLS)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
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
Schwangerschaft
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0549206
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
Descrição

Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0002726
SNOMED CT 2011_0131
17602002
MedDRA 14.1
10002022
LOINC Version 232
E85
ICD-10-CM Version 2010
277.3
UMLS CUI 2011AA
C0700053
SNOMED CT 2011_0131
360465008
MedDRA 14.1
10021230
ICD-10-CM Version 2010
I42.1
UMLS CUI 2011AA
C0003855
SNOMED CT 2011_0131
439470001
MedDRA 14.1
10003226
LOINC Version 232
MTHU011026
Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation
Descrição

Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0012798
SNOMED CT 2011_0131
372695000
LOINC Version 232
MTHU003217
UMLS CUI 2011AA
C2347524
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205173
SNOMED CT 2011_0131
1305003
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
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 22 Years
Item
Alter mindestens 22 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
Item
Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
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)
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)
Left ventricular ejection fraction (LVEF) <= 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented < 12 weeks before randomisation
Item
Left ventricular ejection fraction (LVEF) <= 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented < 12 weeks before randomisation
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
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)
Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr
Item
Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
Item
Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0013227 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
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)
Optimised medical treatment according to the applicable guidelines
Item
Optimised medical treatment according to the applicable guidelines
boolean
C2698650 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1706839 (UMLS CUI 2011AA)
C0220845 (UMLS CUI 2011AA)
Able to provide informed consent
Item
Able to provide informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented < 4 weeks before randomization. Flow measurements have to be performed with nasal cannula
Item
Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented < 4 weeks before randomization. Flow measurements have to be performed with nasal cannula
boolean
C0751762 (UMLS CUI 2011AA)
G47.31 (ICD-10-CM Version 2010)
327.21 (ICD-9-CM Version 2011)
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)
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0162701 (UMLS CUI 2011AA)
60554003 (SNOMED CT 2011_0131)
10053319 (MedDRA 14.1)
89.17 (ICD-9-CM Version 2011)
C0599318 (UMLS CUI 2011AA)
C0807070 (UMLS CUI 2011AA)
MTHU031476 (LOINC Version 232)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted
Item
Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted
boolean
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)
Oxygen saturation at rest during the day 90% at the time of inclusion
Item
Oxygen saturation at rest during the day 90% at the time of inclusion
boolean
C2923814 (UMLS CUI 2011AA)
59417-6 (LOINC Version 232)
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
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 heart failure
Item
Life expectancy < 1 year for diseases unrelated to chronic heart failure
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
C0018821 (UMLS CUI 2011AA)
64915003 (SNOMED CT 2011_0131)
10061026 (MedDRA 14.1)
C1532338 (UMLS CUI 2011AA)
415070008 (SNOMED CT 2011_0131)
10065608 (MedDRA 14.1)
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)
Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
Item
Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
boolean
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C1167956 (UMLS CUI 2011AA)
10059862 (MedDRA 14.1)
C0086960 (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)
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
CL414904 (UMLS CUI 2011AA)
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)
C2004489 (UMLS CUI 2011AA)
78104003 (SNOMED CT 2011_0131)
10067171 (MedDRA 14.1)
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)
Untreated or therapy refractory Restless legs Syndrome (RLS)
Item
Untreated or therapy refractory Restless legs Syndrome (RLS)
boolean
C1518422 (UMLS CUI 2011AA)
CL415147 (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
Schwangerschaft
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
Item
Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
boolean
C0002726 (UMLS CUI 2011AA)
17602002 (SNOMED CT 2011_0131)
10002022 (MedDRA 14.1)
E85 (LOINC Version 232)
277.3 (ICD-10-CM Version 2010)
C0700053 (UMLS CUI 2011AA)
360465008 (SNOMED CT 2011_0131)
10021230 (MedDRA 14.1)
I42.1 (ICD-10-CM Version 2010)
C0003855 (UMLS CUI 2011AA)
439470001 (SNOMED CT 2011_0131)
10003226 (MedDRA 14.1)
MTHU011026 (LOINC Version 232)
Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation
Item
Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation
boolean
C0012798 (UMLS CUI 2011AA)
372695000 (SNOMED CT 2011_0131)
MTHU003217 (LOINC Version 232)
C2347524 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205173 (UMLS CUI 2011AA)
1305003 (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)
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