ID

43261

Beschrijving

ODM derived from http://clinicaltrials.gov/show/NCT00586794

Link

http://clinicaltrials.gov/show/NCT00586794

Trefwoorden

Versies (4)
  1. 09-12-13 09-12-13 - Martin Dugas
  2. 15-04-14 15-04-14 - Julian Varghese
  3. 11-08-14 11-08-14 - Martin Dugas
  4. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility NCT00586794 Pulmonary Arterial Hypertension (PAH)

Duits Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschrijving

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 14 Jahre
Beschrijving

age at least 14 Years

Datatype

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Written informed consent obtained
Beschrijving

Written informed consent obtained

Datatype

boolean

Alias
UMLS CUI 2011AA
C0021430
No participation in another AMG driven study attendancing this treatment protocol
Beschrijving

No participation in another AMG driven study attendancing this treatment protocol

Datatype

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C2827364
UMLS CUI 2011AA
C2348563
Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
Beschrijving

Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0010520
SNOMED CT 2011_0131
119419001
MedDRA 14.1
10011703
ICD-10-CM Version 2010
R23.0
ICD-9-CM Version 2011
782.5
UMLS CUI 2011AA
C0523807
SNOMED CT 2011_0131
264598005
MedDRA 14.1
10033316
UMLS CUI 2011AA
C0034108
SNOMED CT 2011_0131
252465000
MedDRA 14.1
10060209
Clinical indication for the invasive diagnostic procedures planned for the study is given. This is evaluated on the basis of observation before, during and after medicinal therapy)
Beschrijving

Clinical indication for the invasive diagnostic procedures planned for the study is given. This is evaluated on the basis of observation before, during and after medicinal therapy)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0430022
SNOMED CT 2011_0131
103693007
MedDRA 14.1
10061816
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
CL370598
UMLS CUI 2011AA
C0039798
Presence of PAH as diagnosed by invasive methods with Rp:Rs > 0.5 measured at rest, before testing of pulmonary vasodilatory reserve
Beschrijving

Presence of PAH as diagnosed by invasive methods with Rp:Rs > 0.5 measured at rest, before testing of pulmonary vasodilatory reserve

Datatype

boolean

Alias
UMLS CUI 2011AA
C0152171
SNOMED CT 2011_0131
26174007
MedDRA 14.1
10036727
ICD-10-CM Version 2010
I27.0
ICD-9-CM Version 2011
416.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0025663
SNOMED CT 2011_0131
260686004
LOINC Version 232
MTHU024654
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C0039593
UMLS CUI 2011AA
C2709248
SNOMED CT 2011_0131
264164005
LOINC Version 232
MTHU031874
UMLS CUI 2011AA
C0042401
SNOMED CT 2011_0131
30017007
MedDRA 14.1
10047142
UMLS CUI 2011AA
C2347957
Diagnose
Beschrijving

One of the following diagnoses:

Datatype

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
non-corrected large congenital shunting defect at atrial, ventricular or arterial level:
Beschrijving

non-corrected large congenital shunting defect at atrial, ventricular or arterial level:

Datatype

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1947976
UMLS CUI 2011AA
C0549177
SNOMED CT 2011_0131
255509001
UMLS CUI 2011AA
C0009678
UMLS CUI 2011AA
C0232350
SNOMED CT 2011_0131
72884006
MedDRA 14.1
10052664
UMLS CUI 2011AA
C1457869
SNOMED CT 2011_0131
6920004
Partial anomalous pulmonary venous drainage, Partial Anomalous Pulmonary Venous Return
Beschrijving

PAPVD

Datatype

boolean

Alias
UMLS CUI 2011AA
C0158634
SNOMED CT 2011_0131
68237008
MedDRA 14.1
10034056
ICD-10-CM Version 2010
Q26.3
ICD-9-CM Version 2011
747.42
Vorhofseptumdefekt, ASD
Beschrijving

ASD

Datatype

boolean

Alias
UMLS CUI 2011AA
C0018817
SNOMED CT 2011_0131
70142008
MedDRA 14.1
10003664
ICD-10-CM Version 2010
Q21.1
Atrial Septal Defect Sinus Venosus, Sinus venosus atrial septal defect
Beschrijving

SVD

Datatype

boolean

Alias
UMLS CUI 2011AA
C0344730
SNOMED CT 2011_0131
95268002
Ventrikelseptumdefekt, VSD, Herzkammerscheidewanddefekt
Beschrijving

VSD

Datatype

boolean

Alias
UMLS CUI 2011AA
C0018818
SNOMED CT 2011_0131
30288003
MedDRA 14.1
10047298
ICD-10-CM Version 2010
Q21.0
ICD-9-CM Version 2011
745.4
Atrioventricular septal defect, Atrioventricular septal defect and common atrioventricular junction
Beschrijving

AVSD

Datatype

boolean

Alias
UMLS CUI 2011AA
C0344783
SNOMED CT 2011_0131
253414002
MedDRA 14.1
10063836
ICD-10-CM Version 2010
Q21.2
TAC
Beschrijving

TAC

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205106
SNOMED CT 2011_0131
62824007
UMLS CUI 2011AA
C0597891
Aortopulmonary window, Aortopulmonary septal defect
Beschrijving

APW

Datatype

boolean

Alias
UMLS CUI 2011AA
C0003516
SNOMED CT 2011_0131
17024001
MedDRA 14.1
10063732
ICD-10-CM Version 2010
Q21.4
Ductus arteriosus apertus persistens
Beschrijving

PDA

Datatype

boolean

Alias
UMLS CUI 2011AA
C0013274
SNOMED CT 2011_0131
83330001
MedDRA 14.1
10034130
ICD-10-CM Version 2010
Q25.0
ICD-9-CM Version 2011
747.0
combinations thereof
Beschrijving

combinations thereof

Datatype

boolean

Alias
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
CL414621
Surgically corrected shunting defect (diagnoses as above) with significant residual defect
Beschrijving

Surgically corrected shunting defect (diagnoses as above) with significant residual defect

Datatype

boolean

Alias
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C1947976
UMLS CUI 2011AA
C0232350
SNOMED CT 2011_0131
72884006
MedDRA 14.1
10052664
UMLS CUI 2011AA
C1457869
SNOMED CT 2011_0131
6920004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C1609982
SNOMED CT 2011_0131
65320000
UMLS CUI 2011AA
C1457869
SNOMED CT 2011_0131
6920004
Other diagnoses with univentricular physiology/ hemodynamics.
Beschrijving

Other diagnoses with univentricular physiology/ hemodynamics.

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0031843
UMLS CUI 2011AA
C0019010
Ausschlusskriterien
Beschrijving

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
pregnancy or lactation
Beschrijving

pregnancy or lactation

Datatype

boolean

women of child-bearing age who are sexually active without practising highly effective methods of contraception
Beschrijving

women of child-bearing age who are sexually active without practising highly effective methods of contraception

Datatype

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
Beschrijving

any diseases or impairment that, in the opinion of the investigator exclude a subject from participation

Datatype

boolean

Alias
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
substance abuse (alcohol, medicines, drugs)
Beschrijving

Substance abuse

Datatype

boolean

Alias
UMLS CUI-1
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
SNOMED CT 2011_0131
417928002
MedDRA 14.1
10000341
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
Beschrijving

other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0205486
SNOMED CT 2011_0131
60224009
UMLS CUI 2011AA
C0683578
UMLS CUI 2011AA
C0851364
MedDRA 14.1
10041244
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
insufficient compliance
Beschrijving

insufficient compliance

Datatype

boolean

Alias
UMLS CUI 2011AA
C1321605
missing willingness to storaging and transferring pseudonymous disease data within this study.
Beschrijving

missing willingness to storaging and transferring pseudonymous disease data within this study.

Datatype

boolean

Alias
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1698986
SNOMED CT 2011_0131
440276004
HL7 V3 2006_05
STORE
UMLS CUI 2011AA
C1705822
LOINC Version 232
MTHU034962
UMLS CUI 2011AA
C0033824
HL7 V3 2006_05
P
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0681873
subjects who are not able to perform Cardio-Pulmonary Exercise Testing (CPX).
Beschrijving

subjects who are not able to perform Cardio-Pulmonary Exercise Testing (CPX).

Datatype

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C2959886
SNOMED CT 2011_0131
447346005
pulmonary hypertension secondary to any etiology other than those specified in the inclusion criteria
Beschrijving

pulmonary hypertension secondary to any etiology other than those specified in the inclusion criteria

Datatype

boolean

Alias
UMLS CUI 2011AA
C0020542
SNOMED CT 2011_0131
70995007
MedDRA 14.1
10037400
ICD-10-CM Version 2010
I27.2
ICD-9-CM Version 2011
E13539
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0205369
SNOMED CT 2011_0131
69658003
UMLS CUI 2011AA
CL425202
subjects with known intolerance of NO and iloprost or their constituents
Beschrijving

subjects with known intolerance of NO and iloprost or their constituents

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
CL415164
HL7 V3 2006_05
OINT
UMLS CUI 2011AA
C0028128
SNOMED CT 2011_0131
6710000
UMLS CUI 2011AA
C0079594
SNOMED CT 2011_0131
395740002
UMLS CUI 2011AA
C0729650
SNOMED CT 2011_0131
312297002
acute decompensated heart failure within the 7 days before the invasive diagnostic procedure
Beschrijving

acute decompensated heart failure within the 7 days before the invasive diagnostic procedure

Datatype

boolean

Alias
UMLS CUI 2011AA
C1609524
MedDRA 14.1
10064653
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
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0430022
SNOMED CT 2011_0131
103693007
MedDRA 14.1
10061816
clinically significant haemoptysis within the last 6 months
Beschrijving

clinically significant haemoptysis within the last 6 months

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0019079
SNOMED CT 2011_0131
66857006
MedDRA 14.1
10018964
ICD-10-CM Version 2010
R04.2
ICD-9-CM Version 2011
786.3
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
hemodynamic instability which would represent an unjustifiable risk during testing of pulmonary arterial vasoreagibility
Beschrijving

hemodynamic instability which would represent an unjustifiable risk during testing of pulmonary arterial vasoreagibility

Datatype

boolean

Alias
UMLS CUI 2011AA
C0948268
SNOMED CT 2011_0131
422773005
MedDRA 14.1
10052076
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0039593
UMLS CUI 2011AA
C0034052
SNOMED CT 2011_0131
81040000
LOINC Version 232
MTHU012075
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0443286
SNOMED CT 2011_0131
263851003
LOINC Version 232
MTHU014636
arterial hypotension (as defined by age-specific values)
Beschrijving

arterial hypotension (as defined by age-specific values)

Datatype

boolean

Alias
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
C1704788
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C1552740
HL7 V3 2006_05
INSTANCE
UMLS CUI 2011AA
C1522609
Anämie
Beschrijving

anemia (Hb < 10 g/dl)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0002871
SNOMED CT 2011_0131
271737000
MedDRA 14.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE 1105E
E10010
decompensated symptomatic policythemia; (details: 4.2.2. exclusion criteria)
Beschrijving

decompensated symptomatic policythemia; (details: 4.2.2. exclusion criteria)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205434
SNOMED CT 2011_0131
5650002
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0032461
SNOMED CT 2011_0131
127062003
MedDRA 14.1
10036051
ICD-10-CM Version 2010
D75.1
Thrombocytopenia
Beschrijving

thrombocytopenia (< 50.000/µl)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0040034
SNOMED CT 2011_0131
302215000
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE 1105E
E12207
secondary impairment of organic function:
Beschrijving

secondary impairment of organic function:

Datatype

boolean

Alias
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0678852
impairment of renal function (GFR < 30 ml/min/1,73 m2 BSA)
Beschrijving

impairment of renal function (GFR < 30 ml/min/1,73 m2 BSA)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
UMLS CUI 2011AA
C0005902
SNOMED CT 2011_0131
128178001
MedDRA 14.1
10050311
impairment of hepatic function (ALT and/or AST > 3 x ULN and bilirubin ≥ 2 mg/dl)
Beschrijving

impairment of hepatic function (ALT and/or AST > 3 x ULN and bilirubin ≥ 2 mg/dl)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
MedDRA 14.1
10003543
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
other sources of pulmonary blood flow which prohibit measurement of the blood flow into the lungs and therefore of the pulmonary vascular resistance:
Beschrijving

other sources of pulmonary blood flow which prohibit measurement of the blood flow into the lungs and therefore of the pulmonary vascular resistance:

Datatype

boolean

Alias
UMLS CUI 2011AA
C2709248
SNOMED CT 2011_0131
264164005
LOINC Version 232
MTHU031874
UMLS CUI 2011AA
C0005775
SNOMED CT 2011_0131
58190003
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C0242485
SNOMED CT 2011_0131
122869004
LOINC Version 232
MTHU003137
UMLS CUI 2011AA
C0005775
SNOMED CT 2011_0131
58190003
UMLS CUI 2011AA
C0024109
SNOMED CT 2011_0131
39607008
LOINC Version 232
MTHU008683
UMLS CUI 2011AA
C0456261
SNOMED CT 2011_0131
276901002
Glenn shunt, Anastomosis of superior vena cava to pulmonary artery
Beschrijving

Glenn

Datatype

boolean

Alias
UMLS CUI 2011AA
C0190763
SNOMED CT 2011_0131
175249005
ICD-9-CM Version 2011
39.21
BT - Blalock-Taussig shunt, Subclavian to pulmonary artery shunt operation
Beschrijving

BT shunt

Datatype

boolean

Alias
UMLS CUI 2011AA
C0397553
SNOMED CT 2011_0131
13662000
MedDRA 14.1
10069411
significant number of MAPCAs; (details: 4.2.2. exclusion criteria)
Beschrijving

significant number of MAPCAs; (details: 4.2.2. exclusion criteria)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0237753
SNOMED CT 2011_0131
260299005
LOINC Version 232
MTHU024869
UMLS CUI 2011AA
C0431506
SNOMED CT 2011_0131
253689007
MedDRA 14.1
10064207
Obstruction of pulmonary outflow tract
Beschrijving

Obstruction of pulmonary blood outflow:

Datatype

boolean

Alias
UMLS CUI 2011AA
CL431203
SNOMED CT 2011_0131
449120006
obstruction of pulmonary venous return
Beschrijving

obstruction of pulmonary venous return

Datatype

boolean

Alias
UMLS CUI 2011AA
C0028778
SNOMED CT 2011_0131
26036001
MedDRA 14.1
10061876
UMLS CUI 2011AA
C0034090
SNOMED CT 2011_0131
122972007
LOINC Version 232
MTHU003054
UMLS CUI 2011AA
C1388021
mitral valve dysfunction
Beschrijving

mitral valve dysfunction

Datatype

boolean

Alias
UMLS CUI 2011AA
C0026264
SNOMED CT 2011_0131
91134007
LOINC Version 232
MTHU002664
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
Left heart diseases:
Beschrijving

Left heart diseases:

Datatype

boolean

Alias
UMLS CUI 2011AA
C0225809
SNOMED CT 2011_0131
17398003
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
aortic or mitral valve disease (more severe than "mild")
Beschrijving

aortic or mitral valve disease (more severe than "mild")

Datatype

boolean

Alias
UMLS CUI 2011AA
C1260873
SNOMED CT 2011_0131
8722008
MedDRA 14.1
10061589
ICD-9-CM Version 2011
424.1
CTCAE 1105E
E10071
UMLS CUI 2011AA
C0026264
SNOMED CT 2011_0131
91134007
LOINC Version 232
MTHU002664
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
restrictive or congestive cardiomyopathy
Beschrijving

restrictive or congestive cardiomyopathy

Datatype

boolean

Alias
UMLS CUI 2011AA
C0007196
SNOMED CT 2011_0131
90828009
MedDRA 14.1
10038748
CTCAE 1105E
E10192
UMLS CUI 2011AA
C0007193
SNOMED CT 2011_0131
399020009
MedDRA 14.1
10056370
ICD-10-CM Version 2010
I42.0
PCWP/LVEDP > 15 mmHg
Beschrijving

PCWP/LVEDP > 15 mmHg

Datatype

boolean

Alias
UMLS CUI 2011AA
C0034094
SNOMED CT 2011_0131
118433006
MedDRA 14.1
10037325
UMLS CUI 2011AA
C0456190
SNOMED CT 2011_0131
276781007
symptomatic coronary artery disease
Beschrijving

symptomatic coronary artery disease

Datatype

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
Significant valvular diseases other than tricuspid or pulmonary regurgitation (these are not exclusion criteria; details: 4.2.2. exclusion criteria).
Beschrijving

Significant valvular diseases other than tricuspid or pulmonary regurgitation (these are not exclusion criteria; details: 4.2.2. exclusion criteria).

Datatype

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0026265
SNOMED CT 2011_0131
11851006
MedDRA 14.1
10061532
ICD-9-CM Version 2011
424.0
CTCAE 1105E
E10134
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
CL354298
MedDRA 14.1
10049217
UMLS CUI 2011AA
C0034088
SNOMED CT 2011_0131
91434003
MedDRA 14.1
10037448
PERICARDIAL CONSTRICTION
Beschrijving

Pericardial constriction

Datatype

boolean

Alias
UMLS CUI 2011AA
C0240709
History of stroke, myocardial infarction or life-threatening arrhythmia within the 6 months before screening
Beschrijving

History of stroke, myocardial infarction or life-threatening arrhythmia within the 6 months before screening

Datatype

boolean

Alias
UMLS CUI 2011AA
C1275835
SNOMED CT 2011_0131
399211009
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
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
C1610642
SNOMED CT 2011_0131
440181000
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Bronchopulmonary dysplasia (BPD) and other chronic lung diseases
Beschrijving

Bronchopulmonary dysplasia (BPD) and other chronic lung diseases

Datatype

boolean

Alias
UMLS CUI 2011AA
C0006287
SNOMED CT 2011_0131
67569000
MedDRA 14.1
10006475
ICD-10-CM Version 2010
P27.8
UMLS CUI 2011AA
C0746102
SNOMED CT 2011_0131
413839001
History of significant pulmonary embolism
Beschrijving

History of significant pulmonary embolism

Datatype

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0034065
SNOMED CT 2011_0131
59282003
MedDRA 14.1
10037377
ICD-10-CM Version 2010
I26
ICD-9-CM Version 2011
415.1
Other relevant diseases (e.g. HIV, diabetes mellitus requiring medical treatment)
Beschrijving

Other relevant diseases (e.g. HIV, diabetes mellitus requiring medical treatment)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0418981
SNOMED CT 2011_0131
243121000
Subjects with trisomy 21 (reproducibility of 6-MWT and CPX doubtful; communication as to side effects and subjective quality of life doubtful)
Beschrijving

Subjects with trisomy 21 (reproducibility of 6-MWT and CPX doubtful; communication as to side effects and subjective quality of life doubtful)

Datatype

boolean

Alias
UMLS CUI 2011AA
CL333417
UMLS CUI 2011AA
C0750558
UMLS CUI 2011AA
C0035149
UMLS CUI 2011AA
C0430515
SNOMED CT 2011_0131
252478000
UMLS CUI 2011AA
C2959886
SNOMED CT 2011_0131
447346005
UMLS CUI 2011AA
C0750558
UMLS CUI 2011AA
C0009452
SNOMED CT 2011_0131
263536004
LOINC Version 232
MTHU021752
UMLS CUI 2011AA
C0879626
SNOMED CT 2011_0131
281647001
MedDRA 14.1
10067484
UMLS CUI 2011AA
C0439655
SNOMED CT 2011_0131
255362007
LOINC Version 232
MTHU036449
UMLS CUI 2011AA
C0518214
SNOMED CT 2011_0131
405152002
all contraindications against the study medication (see also "4.2.3 concomitant medication")
Beschrijving

all contraindications against the study medication (see also "4.2.3 concomitant medication")

Datatype

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
hypersensitivity against the active ingredients as well as supplementaries
Beschrijving

hypersensitivity against the active ingredients as well as supplementaries

Datatype

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1372955
HL7 V3 2006_05
ACTI
UMLS CUI 2011AA
C2348609
UMLS CUI 2011AA
C1254351
patients who lost vision on one eye due to a non arteriitic anterior ischaemic neuropathy of the opticus (NAION).
Beschrijving

patients who lost vision on one eye due to a non arteriitic anterior ischaemic neuropathy of the opticus (NAION).

Datatype

boolean

Alias
UMLS CUI 2011AA
CL355222
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C1852242
MedDRA 14.1
10068245
Prohibited concomitant medication:
Beschrijving

Prohibited concomitant medication:

Datatype

boolean

Alias
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C2347852
Any medication listed below which has not been discontinued at least 30 days prior to screening. Specific pulmonary vasodilators during cardiac catheterization are allowed.
Beschrijving

Any medication listed below which has not been discontinued at least 30 days prior to screening. Specific pulmonary vasodilators during cardiac catheterization are allowed.

Datatype

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0745732
UMLS CUI 2011AA
CL384716
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1444662
SNOMED CT 2011_0131
410546004
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
C1409616
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C1552740
UMLS CUI 2011AA
C2709248
SNOMED CT 2011_0131
264164005
LOINC Version 232
MTHU031874
UMLS CUI 2011AA
C0042402
SNOMED CT 2011_0131
58944007
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0018795
SNOMED CT 2011_0131
41976001
MedDRA 14.1
10007815
ICD-9-CM Version 2011
37.21
Unspecified concomitant medication
Beschrijving

Unspecified concomitant medication

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205370
SNOMED CT 2011_0131
10003008
UMLS CUI 2011AA
C2347852
Other significant medication (a.o. chronic intake of systemic immunosuppression as e.g. systemic glucocorticoids, cytostatic drugs, ciclosporin)
Beschrijving

Other significant medication (a.o. chronic intake of systemic immunosuppression as e.g. systemic glucocorticoids, cytostatic drugs, ciclosporin)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0017710
SNOMED CT 2011_0131
419933005
UMLS CUI 2011AA
C0010858
SNOMED CT 2011_0131
373221003
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
Instable medication (details: 4.2.5 prohibited concomitant medication):
Beschrijving

Instable medication (details: 4.2.5 prohibited concomitant medication):

Datatype

boolean

Alias
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0013227
begin of a new medication regimen within the last 30 days before screening
Beschrijving

begin of a new medication regimen within the last 30 days before screening

Datatype

boolean

Alias
UMLS CUI 2011AA
CL414705
UMLS CUI 2011AA
C0205314
SNOMED CT 2011_0131
7147002
UMLS CUI 2011AA
C1829817
LOINC Version 232
MTHU013187
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
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
C1409616
change in the dosage of existing medication within the last 7 days before cardiac catheterization
Beschrijving

change in the dosage of existing medication within the last 7 days before cardiac catheterization

Datatype

boolean

Alias
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C1517741
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
C0018795
SNOMED CT 2011_0131
41976001
MedDRA 14.1
10007815
ICD-9-CM Version 2011
37.21
Existing anti-pulmonary hypertensive medication (in any form) with:
Beschrijving

Existing anti-pulmonary hypertensive medication (in any form) with:

Datatype

boolean

Alias
UMLS CUI 2011AA
C2709248
SNOMED CT 2011_0131
264164005
LOINC Version 232
MTHU031874
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
PDE-5 antagonists (e.g. sildenafil)
Beschrijving

PDE-5 antagonists (e.g. sildenafil)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0757672
UMLS CUI 2011AA
C0243076
UMLS CUI 2011AA
C2923059
UMLS CUI 2011AA
C0529793
SNOMED CT 2011_0131
372572000
prostanoids (e.g. iloprost, prostacyclin, beraprost) In case the patient is stable and on Bosentan therapy at least for 6 months. Bosentan (Tracleer) is unprohibited as concomitant medication.
Beschrijving

prostanoids (e.g. iloprost, prostacyclin, beraprost) In case the patient is stable and on Bosentan therapy at least for 6 months. Bosentan (Tracleer) is unprohibited as concomitant medication.

Datatype

boolean

Alias
UMLS CUI 2011AA
C0033554
SNOMED CT 2011_0131
418226006
UMLS CUI 2011AA
C0079594
SNOMED CT 2011_0131
395740002
UMLS CUI 2011AA
C0033567
SNOMED CT 2011_0131
372513003
UMLS CUI 2011AA
C0053336
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0252643
SNOMED CT 2011_0131
385559004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C0252643
SNOMED CT 2011_0131
385559004
UMLS CUI 2011AA
C2347852
Other medication with vascular action:
Beschrijving

Other medication with vascular action:

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1801960
UMLS CUI 2011AA
CL415100
Alpha-Blocker
Beschrijving

alpha blockers

Datatype

boolean

Alias
UMLS CUI 2011AA
C0001641
SNOMED CT 2011_0131
373275009
L-arginin (acts through NO axis)
Beschrijving

L-arginin (acts through NO axis)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0003765
SNOMED CT 2011_0131
52625008
LOINC Version 232
MTHU004112
UMLS CUI 2011AA
C0028128
SNOMED CT 2011_0131
6710000
UMLS CUI 2011AA
C1522496
ritonavir, nicorandil (act through K+ channels)
Beschrijving

ritonavir, nicorandil (act through K+ channels)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0292818
SNOMED CT 2011_0131
386896009
LOINC Version 232
MTHU013855
UMLS CUI 2011AA
C0068700
SNOMED CT 2011_0131
395809002
UMLS CUI 2011AA
C0597277
UMLS CUI 2011AA
C1706095
Medication that is not compatible with sildenafil or interferes with the metabolism:
Beschrijving

Medication that is not compatible with sildenafil or interferes with the metabolism:

Datatype

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0679426
UMLS CUI 2011AA
C0529793
SNOMED CT 2011_0131
372572000
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0025519
SNOMED CT 2011_0131
47722004
cytochrome P450-CYP2C9 and CYP3A4 inhibitors (e.g. erythromycin/ketoconazole/itraconazole/protease inhibitors)
Beschrijving

cytochrome P450-CYP2C9 and CYP3A4 inhibitors (e.g. erythromycin/ketoconazole/itraconazole/protease inhibitors)

Datatype

boolean

Alias
UMLS CUI 2011AA
C1828473
SNOMED CT 2011_0131
422602005
UMLS CUI 2011AA
C1142644
SNOMED CT 2011_0131
422741004
UMLS CUI 2011AA
C0243077
UMLS CUI 2011AA
C0014806
SNOMED CT 2011_0131
30427009
LOINC Version 232
MTHU003043
UMLS CUI 2011AA
C0022625
SNOMED CT 2011_0131
387216007
LOINC Version 232
MTHU002299
UMLS CUI 2011AA
C0064113
SNOMED CT 2011_0131
387532006
LOINC Version 232
MTHU002298
UMLS CUI 2011AA
C0033607
SNOMED CT 2011_0131
412127001
any existing medication that, in the opinion of the investigator, may interfere with sildenafil treatment.
Beschrijving

any existing medication that, in the opinion of the investigator, may interfere with sildenafil treatment.

Datatype

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0529793
SNOMED CT 2011_0131
372572000
UMLS CUI 2011AA
C0039798
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Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 14 Years
Item
Alter mindestens 14 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent obtained
Item
Written informed consent obtained
boolean
C0021430 (UMLS CUI 2011AA)
No participation in another AMG driven study attendancing this treatment protocol
Item
No participation in another AMG driven study attendancing this treatment protocol
boolean
C1518422 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2827364 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
Item
Presence of cyanosis with < 93 % arterial oxygen saturation (measured by transcutaneous pulse oximetry)
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0010520 (UMLS CUI 2011AA)
119419001 (SNOMED CT 2011_0131)
10011703 (MedDRA 14.1)
R23.0 (ICD-10-CM Version 2010)
782.5 (ICD-9-CM Version 2011)
C0523807 (UMLS CUI 2011AA)
264598005 (SNOMED CT 2011_0131)
10033316 (MedDRA 14.1)
C0034108 (UMLS CUI 2011AA)
252465000 (SNOMED CT 2011_0131)
10060209 (MedDRA 14.1)
Clinical indication for the invasive diagnostic procedures planned for the study is given. This is evaluated on the basis of observation before, during and after medicinal therapy)
Item
Clinical indication for the invasive diagnostic procedures planned for the study is given. This is evaluated on the basis of observation before, during and after medicinal therapy)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
CL335836 (UMLS CUI 2011AA)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0430022 (UMLS CUI 2011AA)
103693007 (SNOMED CT 2011_0131)
10061816 (MedDRA 14.1)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
CL370598 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Presence of PAH as diagnosed by invasive methods with Rp:Rs > 0.5 measured at rest, before testing of pulmonary vasodilatory reserve
Item
Presence of PAH as diagnosed by invasive methods with Rp:Rs > 0.5 measured at rest, before testing of pulmonary vasodilatory reserve
boolean
C0152171 (UMLS CUI 2011AA)
26174007 (SNOMED CT 2011_0131)
10036727 (MedDRA 14.1)
I27.0 (ICD-10-CM Version 2010)
416.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C0039593 (UMLS CUI 2011AA)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0042401 (UMLS CUI 2011AA)
30017007 (SNOMED CT 2011_0131)
10047142 (MedDRA 14.1)
C2347957 (UMLS CUI 2011AA)
One of the following diagnoses:
Item
Diagnose
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
non-corrected large congenital shunting defect at atrial, ventricular or arterial level:
Item
non-corrected large congenital shunting defect at atrial, ventricular or arterial level:
boolean
C1518422 (UMLS CUI 2011AA)
C1947976 (UMLS CUI 2011AA)
C0549177 (UMLS CUI 2011AA)
255509001 (SNOMED CT 2011_0131)
C0009678 (UMLS CUI 2011AA)
C0232350 (UMLS CUI 2011AA)
72884006 (SNOMED CT 2011_0131)
10052664 (MedDRA 14.1)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
PAPVD
Item
Partial anomalous pulmonary venous drainage, Partial Anomalous Pulmonary Venous Return
boolean
C0158634 (UMLS CUI 2011AA)
68237008 (SNOMED CT 2011_0131)
10034056 (MedDRA 14.1)
Q26.3 (ICD-10-CM Version 2010)
747.42 (ICD-9-CM Version 2011)
ASD
Item
Vorhofseptumdefekt, ASD
boolean
C0018817 (UMLS CUI 2011AA)
70142008 (SNOMED CT 2011_0131)
10003664 (MedDRA 14.1)
Q21.1 (ICD-10-CM Version 2010)
SVD
Item
Atrial Septal Defect Sinus Venosus, Sinus venosus atrial septal defect
boolean
C0344730 (UMLS CUI 2011AA)
95268002 (SNOMED CT 2011_0131)
VSD
Item
Ventrikelseptumdefekt, VSD, Herzkammerscheidewanddefekt
boolean
C0018818 (UMLS CUI 2011AA)
30288003 (SNOMED CT 2011_0131)
10047298 (MedDRA 14.1)
Q21.0 (ICD-10-CM Version 2010)
745.4 (ICD-9-CM Version 2011)
AVSD
Item
Atrioventricular septal defect, Atrioventricular septal defect and common atrioventricular junction
boolean
C0344783 (UMLS CUI 2011AA)
253414002 (SNOMED CT 2011_0131)
10063836 (MedDRA 14.1)
Q21.2 (ICD-10-CM Version 2010)
TAC
Item
TAC
boolean
C0205106 (UMLS CUI 2011AA)
62824007 (SNOMED CT 2011_0131)
C0597891 (UMLS CUI 2011AA)
APW
Item
Aortopulmonary window, Aortopulmonary septal defect
boolean
C0003516 (UMLS CUI 2011AA)
17024001 (SNOMED CT 2011_0131)
10063732 (MedDRA 14.1)
Q21.4 (ICD-10-CM Version 2010)
PDA
Item
Ductus arteriosus apertus persistens
boolean
C0013274 (UMLS CUI 2011AA)
83330001 (SNOMED CT 2011_0131)
10034130 (MedDRA 14.1)
Q25.0 (ICD-10-CM Version 2010)
747.0 (ICD-9-CM Version 2011)
combinations thereof
Item
combinations thereof
boolean
C1947911 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Surgically corrected shunting defect (diagnoses as above) with significant residual defect
Item
Surgically corrected shunting defect (diagnoses as above) with significant residual defect
boolean
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C1947976 (UMLS CUI 2011AA)
C0232350 (UMLS CUI 2011AA)
72884006 (SNOMED CT 2011_0131)
10052664 (MedDRA 14.1)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C1609982 (UMLS CUI 2011AA)
65320000 (SNOMED CT 2011_0131)
C1457869 (UMLS CUI 2011AA)
6920004 (SNOMED CT 2011_0131)
Other diagnoses with univentricular physiology/ hemodynamics.
Item
Other diagnoses with univentricular physiology/ hemodynamics.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0031843 (UMLS CUI 2011AA)
C0019010 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
pregnancy or lactation
Item
pregnancy or lactation
boolean
women of child-bearing age who are sexually active without practising highly effective methods of contraception
Item
women of child-bearing age who are sexually active without practising highly effective methods of contraception
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1148523 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
Item
any diseases or impairment that, in the opinion of the investigator exclude a subject from participation
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
Substance abuse
Item
substance abuse (alcohol, medicines, drugs)
boolean
C0740858 (UMLS CUI-1)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
417928002 (SNOMED CT 2011_0131)
10000341 (MedDRA 14.1)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
Item
other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
boolean
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0205486 (UMLS CUI 2011AA)
60224009 (SNOMED CT 2011_0131)
C0683578 (UMLS CUI 2011AA)
C0851364 (UMLS CUI 2011AA)
10041244 (MedDRA 14.1)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
insufficient compliance
Item
insufficient compliance
boolean
C1321605 (UMLS CUI 2011AA)
missing willingness to storaging and transferring pseudonymous disease data within this study.
Item
missing willingness to storaging and transferring pseudonymous disease data within this study.
boolean
C1705492 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1698986 (UMLS CUI 2011AA)
440276004 (SNOMED CT 2011_0131)
STORE (HL7 V3 2006_05)
C1705822 (UMLS CUI 2011AA)
MTHU034962 (LOINC Version 232)
C0033824 (UMLS CUI 2011AA)
P (HL7 V3 2006_05)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0681873 (UMLS CUI 2011AA)
subjects who are not able to perform Cardio-Pulmonary Exercise Testing (CPX).
Item
subjects who are not able to perform Cardio-Pulmonary Exercise Testing (CPX).
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C2959886 (UMLS CUI 2011AA)
447346005 (SNOMED CT 2011_0131)
pulmonary hypertension secondary to any etiology other than those specified in the inclusion criteria
Item
pulmonary hypertension secondary to any etiology other than those specified in the inclusion criteria
boolean
C0020542 (UMLS CUI 2011AA)
70995007 (SNOMED CT 2011_0131)
10037400 (MedDRA 14.1)
I27.2 (ICD-10-CM Version 2010)
E13539 (ICD-9-CM Version 2011)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0205369 (UMLS CUI 2011AA)
69658003 (SNOMED CT 2011_0131)
CL425202 (UMLS CUI 2011AA)
subjects with known intolerance of NO and iloprost or their constituents
Item
subjects with known intolerance of NO and iloprost or their constituents
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
CL415164 (UMLS CUI 2011AA)
OINT (HL7 V3 2006_05)
C0028128 (UMLS CUI 2011AA)
6710000 (SNOMED CT 2011_0131)
C0079594 (UMLS CUI 2011AA)
395740002 (SNOMED CT 2011_0131)
C0729650 (UMLS CUI 2011AA)
312297002 (SNOMED CT 2011_0131)
acute decompensated heart failure within the 7 days before the invasive diagnostic procedure
Item
acute decompensated heart failure within the 7 days before the invasive diagnostic procedure
boolean
C1609524 (UMLS CUI 2011AA)
10064653 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0430022 (UMLS CUI 2011AA)
103693007 (SNOMED CT 2011_0131)
10061816 (MedDRA 14.1)
clinically significant haemoptysis within the last 6 months
Item
clinically significant haemoptysis within the last 6 months
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0019079 (UMLS CUI 2011AA)
66857006 (SNOMED CT 2011_0131)
10018964 (MedDRA 14.1)
R04.2 (ICD-10-CM Version 2010)
786.3 (ICD-9-CM Version 2011)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
hemodynamic instability which would represent an unjustifiable risk during testing of pulmonary arterial vasoreagibility
Item
hemodynamic instability which would represent an unjustifiable risk during testing of pulmonary arterial vasoreagibility
boolean
C0948268 (UMLS CUI 2011AA)
422773005 (SNOMED CT 2011_0131)
10052076 (MedDRA 14.1)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0039593 (UMLS CUI 2011AA)
C0034052 (UMLS CUI 2011AA)
81040000 (SNOMED CT 2011_0131)
MTHU012075 (LOINC Version 232)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0443286 (UMLS CUI 2011AA)
263851003 (SNOMED CT 2011_0131)
MTHU014636 (LOINC Version 232)
arterial hypotension (as defined by age-specific values)
Item
arterial hypotension (as defined by age-specific values)
boolean
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)
C1704788 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C1522609 (UMLS CUI 2011AA)
anemia (Hb < 10 g/dl)
Item
Anämie
boolean
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
decompensated symptomatic policythemia; (details: 4.2.2. exclusion criteria)
Item
decompensated symptomatic policythemia; (details: 4.2.2. exclusion criteria)
boolean
C0205434 (UMLS CUI 2011AA)
5650002 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0032461 (UMLS CUI 2011AA)
127062003 (SNOMED CT 2011_0131)
10036051 (MedDRA 14.1)
D75.1 (ICD-10-CM Version 2010)
thrombocytopenia (< 50.000/µl)
Item
Thrombocytopenia
boolean
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
secondary impairment of organic function:
Item
secondary impairment of organic function:
boolean
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0678852 (UMLS CUI 2011AA)
impairment of renal function (GFR < 30 ml/min/1,73 m2 BSA)
Item
impairment of renal function (GFR < 30 ml/min/1,73 m2 BSA)
boolean
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C0005902 (UMLS CUI 2011AA)
128178001 (SNOMED CT 2011_0131)
10050311 (MedDRA 14.1)
impairment of hepatic function (ALT and/or AST > 3 x ULN and bilirubin ≥ 2 mg/dl)
Item
impairment of hepatic function (ALT and/or AST > 3 x ULN and bilirubin ≥ 2 mg/dl)
boolean
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
10003543 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
other sources of pulmonary blood flow which prohibit measurement of the blood flow into the lungs and therefore of the pulmonary vascular resistance:
Item
other sources of pulmonary blood flow which prohibit measurement of the blood flow into the lungs and therefore of the pulmonary vascular resistance:
boolean
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0005775 (UMLS CUI 2011AA)
58190003 (SNOMED CT 2011_0131)
C0683610 (UMLS CUI 2011AA)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)
C0005775 (UMLS CUI 2011AA)
58190003 (SNOMED CT 2011_0131)
C0024109 (UMLS CUI 2011AA)
39607008 (SNOMED CT 2011_0131)
MTHU008683 (LOINC Version 232)
C0456261 (UMLS CUI 2011AA)
276901002 (SNOMED CT 2011_0131)
Glenn
Item
Glenn shunt, Anastomosis of superior vena cava to pulmonary artery
boolean
C0190763 (UMLS CUI 2011AA)
175249005 (SNOMED CT 2011_0131)
39.21 (ICD-9-CM Version 2011)
BT shunt
Item
BT - Blalock-Taussig shunt, Subclavian to pulmonary artery shunt operation
boolean
C0397553 (UMLS CUI 2011AA)
13662000 (SNOMED CT 2011_0131)
10069411 (MedDRA 14.1)
significant number of MAPCAs; (details: 4.2.2. exclusion criteria)
Item
significant number of MAPCAs; (details: 4.2.2. exclusion criteria)
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0237753 (UMLS CUI 2011AA)
260299005 (SNOMED CT 2011_0131)
MTHU024869 (LOINC Version 232)
C0431506 (UMLS CUI 2011AA)
253689007 (SNOMED CT 2011_0131)
10064207 (MedDRA 14.1)
Obstruction of pulmonary blood outflow:
Item
Obstruction of pulmonary outflow tract
boolean
CL431203 (UMLS CUI 2011AA)
449120006 (SNOMED CT 2011_0131)
obstruction of pulmonary venous return
Item
obstruction of pulmonary venous return
boolean
C0028778 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10061876 (MedDRA 14.1)
C0034090 (UMLS CUI 2011AA)
122972007 (SNOMED CT 2011_0131)
MTHU003054 (LOINC Version 232)
C1388021 (UMLS CUI 2011AA)
mitral valve dysfunction
Item
mitral valve dysfunction
boolean
C0026264 (UMLS CUI 2011AA)
91134007 (SNOMED CT 2011_0131)
MTHU002664 (LOINC Version 232)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
Left heart diseases:
Item
Left heart diseases:
boolean
C0225809 (UMLS CUI 2011AA)
17398003 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
aortic or mitral valve disease (more severe than "mild")
Item
aortic or mitral valve disease (more severe than "mild")
boolean
C1260873 (UMLS CUI 2011AA)
8722008 (SNOMED CT 2011_0131)
10061589 (MedDRA 14.1)
424.1 (ICD-9-CM Version 2011)
E10071 (CTCAE 1105E)
C0026264 (UMLS CUI 2011AA)
91134007 (SNOMED CT 2011_0131)
MTHU002664 (LOINC Version 232)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
restrictive or congestive cardiomyopathy
Item
restrictive or congestive cardiomyopathy
boolean
C0007196 (UMLS CUI 2011AA)
90828009 (SNOMED CT 2011_0131)
10038748 (MedDRA 14.1)
E10192 (CTCAE 1105E)
C0007193 (UMLS CUI 2011AA)
399020009 (SNOMED CT 2011_0131)
10056370 (MedDRA 14.1)
I42.0 (ICD-10-CM Version 2010)
PCWP/LVEDP > 15 mmHg
Item
PCWP/LVEDP > 15 mmHg
boolean
C0034094 (UMLS CUI 2011AA)
118433006 (SNOMED CT 2011_0131)
10037325 (MedDRA 14.1)
C0456190 (UMLS CUI 2011AA)
276781007 (SNOMED CT 2011_0131)
symptomatic coronary artery disease
Item
symptomatic coronary artery disease
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
Significant valvular diseases other than tricuspid or pulmonary regurgitation (these are not exclusion criteria; details: 4.2.2. exclusion criteria).
Item
Significant valvular diseases other than tricuspid or pulmonary regurgitation (these are not exclusion criteria; details: 4.2.2. exclusion criteria).
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0026265 (UMLS CUI 2011AA)
11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
E10134 (CTCAE 1105E)
CL411789 (UMLS CUI 2011AA)
CL354298 (UMLS CUI 2011AA)
10049217 (MedDRA 14.1)
C0034088 (UMLS CUI 2011AA)
91434003 (SNOMED CT 2011_0131)
10037448 (MedDRA 14.1)
Pericardial constriction
Item
PERICARDIAL CONSTRICTION
boolean
C0240709 (UMLS CUI 2011AA)
History of stroke, myocardial infarction or life-threatening arrhythmia within the 6 months before screening
Item
History of stroke, myocardial infarction or life-threatening arrhythmia within the 6 months before screening
boolean
C1275835 (UMLS CUI 2011AA)
399211009 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C1610642 (UMLS CUI 2011AA)
440181000 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Bronchopulmonary dysplasia (BPD) and other chronic lung diseases
Item
Bronchopulmonary dysplasia (BPD) and other chronic lung diseases
boolean
C0006287 (UMLS CUI 2011AA)
67569000 (SNOMED CT 2011_0131)
10006475 (MedDRA 14.1)
P27.8 (ICD-10-CM Version 2010)
C0746102 (UMLS CUI 2011AA)
413839001 (SNOMED CT 2011_0131)
History of significant pulmonary embolism
Item
History of significant pulmonary embolism
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
Other relevant diseases (e.g. HIV, diabetes mellitus requiring medical treatment)
Item
Other relevant diseases (e.g. HIV, diabetes mellitus requiring medical treatment)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0418981 (UMLS CUI 2011AA)
243121000 (SNOMED CT 2011_0131)
Subjects with trisomy 21 (reproducibility of 6-MWT and CPX doubtful; communication as to side effects and subjective quality of life doubtful)
Item
Subjects with trisomy 21 (reproducibility of 6-MWT and CPX doubtful; communication as to side effects and subjective quality of life doubtful)
boolean
CL333417 (UMLS CUI 2011AA)
C0750558 (UMLS CUI 2011AA)
C0035149 (UMLS CUI 2011AA)
C0430515 (UMLS CUI 2011AA)
252478000 (SNOMED CT 2011_0131)
C2959886 (UMLS CUI 2011AA)
447346005 (SNOMED CT 2011_0131)
C0750558 (UMLS CUI 2011AA)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
C0879626 (UMLS CUI 2011AA)
281647001 (SNOMED CT 2011_0131)
10067484 (MedDRA 14.1)
C0439655 (UMLS CUI 2011AA)
255362007 (SNOMED CT 2011_0131)
MTHU036449 (LOINC Version 232)
C0518214 (UMLS CUI 2011AA)
405152002 (SNOMED CT 2011_0131)
all contraindications against the study medication (see also "4.2.3 concomitant medication")
Item
all contraindications against the study medication (see also "4.2.3 concomitant medication")
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
hypersensitivity against the active ingredients as well as supplementaries
Item
hypersensitivity against the active ingredients as well as supplementaries
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1372955 (UMLS CUI 2011AA)
ACTI (HL7 V3 2006_05)
C2348609 (UMLS CUI 2011AA)
C1254351 (UMLS CUI 2011AA)
patients who lost vision on one eye due to a non arteriitic anterior ischaemic neuropathy of the opticus (NAION).
Item
patients who lost vision on one eye due to a non arteriitic anterior ischaemic neuropathy of the opticus (NAION).
boolean
CL355222 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
C1852242 (UMLS CUI 2011AA)
10068245 (MedDRA 14.1)
Prohibited concomitant medication:
Item
Prohibited concomitant medication:
boolean
C0683610 (UMLS CUI 2011AA)
C2347852 (UMLS CUI 2011AA)
Any medication listed below which has not been discontinued at least 30 days prior to screening. Specific pulmonary vasodilators during cardiac catheterization are allowed.
Item
Any medication listed below which has not been discontinued at least 30 days prior to screening. Specific pulmonary vasodilators during cardiac catheterization are allowed.
boolean
C0013227 (UMLS CUI 2011AA)
C0745732 (UMLS CUI 2011AA)
CL384716 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (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)
C1409616 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
C1552740 (UMLS CUI 2011AA)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0042402 (UMLS CUI 2011AA)
58944007 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0018795 (UMLS CUI 2011AA)
41976001 (SNOMED CT 2011_0131)
10007815 (MedDRA 14.1)
37.21 (ICD-9-CM Version 2011)
Unspecified concomitant medication
Item
Unspecified concomitant medication
boolean
C0205370 (UMLS CUI 2011AA)
10003008 (SNOMED CT 2011_0131)
C2347852 (UMLS CUI 2011AA)
Other significant medication (a.o. chronic intake of systemic immunosuppression as e.g. systemic glucocorticoids, cytostatic drugs, ciclosporin)
Item
Other significant medication (a.o. chronic intake of systemic immunosuppression as e.g. systemic glucocorticoids, cytostatic drugs, ciclosporin)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0017710 (UMLS CUI 2011AA)
419933005 (SNOMED CT 2011_0131)
C0010858 (UMLS CUI 2011AA)
373221003 (SNOMED CT 2011_0131)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
Instable medication (details: 4.2.5 prohibited concomitant medication):
Item
Instable medication (details: 4.2.5 prohibited concomitant medication):
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
begin of a new medication regimen within the last 30 days before screening
Item
begin of a new medication regimen within the last 30 days before screening
boolean
CL414705 (UMLS CUI 2011AA)
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C1829817 (UMLS CUI 2011AA)
MTHU013187 (LOINC Version 232)
C0347984 (UMLS CUI 2011AA)
371881003 (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)
C1409616 (UMLS CUI 2011AA)
change in the dosage of existing medication within the last 7 days before cardiac catheterization
Item
change in the dosage of existing medication within the last 7 days before cardiac catheterization
boolean
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0018795 (UMLS CUI 2011AA)
41976001 (SNOMED CT 2011_0131)
10007815 (MedDRA 14.1)
37.21 (ICD-9-CM Version 2011)
Existing anti-pulmonary hypertensive medication (in any form) with:
Item
Existing anti-pulmonary hypertensive medication (in any form) with:
boolean
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
PDE-5 antagonists (e.g. sildenafil)
Item
PDE-5 antagonists (e.g. sildenafil)
boolean
C0757672 (UMLS CUI 2011AA)
C0243076 (UMLS CUI 2011AA)
C2923059 (UMLS CUI 2011AA)
C0529793 (UMLS CUI 2011AA)
372572000 (SNOMED CT 2011_0131)
prostanoids (e.g. iloprost, prostacyclin, beraprost) In case the patient is stable and on Bosentan therapy at least for 6 months. Bosentan (Tracleer) is unprohibited as concomitant medication.
Item
prostanoids (e.g. iloprost, prostacyclin, beraprost) In case the patient is stable and on Bosentan therapy at least for 6 months. Bosentan (Tracleer) is unprohibited as concomitant medication.
boolean
C0033554 (UMLS CUI 2011AA)
418226006 (SNOMED CT 2011_0131)
C0079594 (UMLS CUI 2011AA)
395740002 (SNOMED CT 2011_0131)
C0033567 (UMLS CUI 2011AA)
372513003 (SNOMED CT 2011_0131)
C0053336 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0252643 (UMLS CUI 2011AA)
385559004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C0683610 (UMLS CUI 2011AA)
C0252643 (UMLS CUI 2011AA)
385559004 (SNOMED CT 2011_0131)
C2347852 (UMLS CUI 2011AA)
Other medication with vascular action:
Item
Other medication with vascular action:
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1801960 (UMLS CUI 2011AA)
CL415100 (UMLS CUI 2011AA)
alpha blockers
Item
Alpha-Blocker
boolean
C0001641 (UMLS CUI 2011AA)
373275009 (SNOMED CT 2011_0131)
L-arginin (acts through NO axis)
Item
L-arginin (acts through NO axis)
boolean
C0003765 (UMLS CUI 2011AA)
52625008 (SNOMED CT 2011_0131)
MTHU004112 (LOINC Version 232)
C0028128 (UMLS CUI 2011AA)
6710000 (SNOMED CT 2011_0131)
C1522496 (UMLS CUI 2011AA)
ritonavir, nicorandil (act through K+ channels)
Item
ritonavir, nicorandil (act through K+ channels)
boolean
C0292818 (UMLS CUI 2011AA)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
C0068700 (UMLS CUI 2011AA)
395809002 (SNOMED CT 2011_0131)
C0597277 (UMLS CUI 2011AA)
C1706095 (UMLS CUI 2011AA)
Medication that is not compatible with sildenafil or interferes with the metabolism:
Item
Medication that is not compatible with sildenafil or interferes with the metabolism:
boolean
C0013227 (UMLS CUI 2011AA)
C0679426 (UMLS CUI 2011AA)
C0529793 (UMLS CUI 2011AA)
372572000 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0025519 (UMLS CUI 2011AA)
47722004 (SNOMED CT 2011_0131)
cytochrome P450-CYP2C9 and CYP3A4 inhibitors (e.g. erythromycin/ketoconazole/itraconazole/protease inhibitors)
Item
cytochrome P450-CYP2C9 and CYP3A4 inhibitors (e.g. erythromycin/ketoconazole/itraconazole/protease inhibitors)
boolean
C1828473 (UMLS CUI 2011AA)
422602005 (SNOMED CT 2011_0131)
C1142644 (UMLS CUI 2011AA)
422741004 (SNOMED CT 2011_0131)
C0243077 (UMLS CUI 2011AA)
C0014806 (UMLS CUI 2011AA)
30427009 (SNOMED CT 2011_0131)
MTHU003043 (LOINC Version 232)
C0022625 (UMLS CUI 2011AA)
387216007 (SNOMED CT 2011_0131)
MTHU002299 (LOINC Version 232)
C0064113 (UMLS CUI 2011AA)
387532006 (SNOMED CT 2011_0131)
MTHU002298 (LOINC Version 232)
C0033607 (UMLS CUI 2011AA)
412127001 (SNOMED CT 2011_0131)
any existing medication that, in the opinion of the investigator, may interfere with sildenafil treatment.
Item
any existing medication that, in the opinion of the investigator, may interfere with sildenafil treatment.
boolean
C0013227 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0529793 (UMLS CUI 2011AA)
372572000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
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