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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